Study: NCT01740089

Adverse event: Abnormal uterine bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 101 at risk

Adverse event: phlegmonous appendicitis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 101 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 86 affected / 101 at risk

Adverse event: Asthenia (weakness, fatigue)
Serious: no
Organ System: General disorders
Frequency: 63 affected / 101 at risk

Adverse event: Grade I decreased body weight
Serious: no
Organ System: General disorders
Frequency: 25 affected / 101 at risk

Adverse event: Grade II decreased body weight
Serious: no
Organ System: General disorders
Frequency: 11 affected / 101 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 101 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 101 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 101 at risk

Adverse event: Irritability, emotional lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 101 at risk

Adverse event: Sleep disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 101 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 101 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 101 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 101 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 101 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 101 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 101 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 101 at risk

Adverse event: Dyspnoe (including dyspnoe after exercises)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 101 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 101 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 101 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 101 at risk

Adverse event: Skin itch
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 101 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 101 at risk

Adverse event: Skin dryness and exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 101 at risk

Adverse event: Stomatitis and gingivitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 101 at risk

Adverse event: Blepharitis and conjunctivitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 101 at risk

Adverse event: Rhinitis, nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 101 at risk

Adverse event: Hoarseness, throat irritation, sore throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 101 at risk

Adverse event: Grade 1 leucopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 101 at risk

Adverse event: Grade 2 leucopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 45 affected / 101 at risk

Adverse event: Grade 3 leucopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 101 at risk

Adverse event: Grade 1 neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 101 at risk

Adverse event: Grade 2 neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 36 affected / 101 at risk

Adverse event: Grade 3 neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 101 at risk

Adverse event: Grade 4 neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 101 at risk

Adverse event: Grade 1 lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 101 at risk

Adverse event: Grade 1 thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 47 affected / 101 at risk

Adverse event: Grade 2 thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 101 at risk

Adverse event: Grade 1 anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 73 affected / 101 at risk

Adverse event: Grade 2 anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 101 at risk

Adverse event: Increased TTH level
Serious: no
Organ System: Endocrine disorders
Frequency: 12 affected / 101 at risk

Adverse event: drug-induced pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: phlegmonous appendicitis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 50 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 49 affected / 50 at risk

Adverse event: Asthenia (weakness, fatigue)
Serious: no
Organ System: General disorders
Frequency: 22 affected / 50 at risk

Adverse event: Grade I decreased body weight
Serious: no
Organ System: General disorders
Frequency: 12 affected / 50 at risk

Adverse event: Grade II decreased body weight
Serious: no
Organ System: General disorders
Frequency: 8 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 50 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 50 at risk

Adverse event: Irritability, emotional lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 50 at risk

Adverse event: Sleep disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 50 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 50 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 50 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 50 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 50 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 50 at risk

Adverse event: Skin itch
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 50 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 50 at risk

Adverse event: Skin dryness and exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 50 at risk

Adverse event: Stomatitis and gingivitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Blepharitis and conjunctivitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Hoarseness, throat irritation, sore throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 50 at risk

Adverse event: Grade 1 leucopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 50 at risk

Adverse event: Grade 2 leucopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 50 at risk

Adverse event: Grade 3 leucopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 50 at risk

Adverse event: Grade 1 neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 50 at risk

Adverse event: Grade 2 neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 50 at risk

Adverse event: Grade 3 neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 50 at risk

Adverse event: Grade 4 neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Grade 1 lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 50 at risk

Adverse event: Grade 1 thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 50 at risk

Adverse event: Grade 2 thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Grade 1 anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 50 at risk

Adverse event: Grade 2 anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 50 at risk

Adverse event: Increased TTH level
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 50 at risk