Study: NCT01764022

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Disease progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: lethal outcome
Frequency: 1 affected / 113 at risk

Adverse event: Death for unknown reason
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 113 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Notes: lethal outcome
Frequency: 1 affected / 113 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unknown etiology
Frequency: 1 affected / 113 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 113 at risk

Adverse event: Сervicitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 113 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 64 affected / 113 at risk

Adverse event: Leucocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 113 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 66 affected / 113 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 75 affected / 113 at risk

Adverse event: Trombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 113 at risk

Adverse event: Elevated absolute neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 113 at risk

Adverse event: Elevated hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 113 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 53 affected / 113 at risk

Adverse event: Lymphocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 113 at risk

Adverse event: Erythropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 113 at risk

Adverse event: Polycythaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 113 at risk

Adverse event: Trombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 113 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 39 affected / 113 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 113 at risk

Adverse event: Elevated alkaline phosphotase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 28 affected / 113 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 29 affected / 113 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 24 affected / 113 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 113 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 113 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 113 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 113 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 113 at risk

Adverse event: Bradypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 113 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 113 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: non-specified
Frequency: 13 affected / 113 at risk

Adverse event: Elevated urea
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 113 at risk

Adverse event: Elevated creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 113 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 113 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 113 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 113 at risk

Adverse event: Generalized weakness
Serious: no
Organ System: General disorders
Frequency: 26 affected / 113 at risk

Adverse event: Elevated lactate degydrohenase
Serious: no
Organ System: Investigations
Frequency: 34 affected / 113 at risk

Adverse event: Disease progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: lethal outcome
Frequency: 2 affected / 110 at risk

Adverse event: Death for unknown reason
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: lethal outcome
Frequency: 1 affected / 110 at risk

Adverse event: Paroxism of atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 110 at risk

Adverse event: Ventricular extrasystolone RYAN-1
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Anemia with trombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Diarrhea with vomiting and weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Pneumonitis with Septicemia
Serious: yes
Organ System: Infections and infestations
Notes: lethal outcome
Frequency: 1 affected / 110 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: lethal outcome
Frequency: 1 affected / 110 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Hepatic veins compression
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 110 at risk

Adverse event: Non-Neutropenic Fever
Serious: yes
Organ System: General disorders
Notes: unknown etiology
Frequency: 2 affected / 110 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 54 affected / 110 at risk

Adverse event: Leucocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 35 affected / 110 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 56 affected / 110 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 73 affected / 110 at risk

Adverse event: Trombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 110 at risk

Adverse event: Elevated absolute neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 110 at risk

Adverse event: Elevated hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 110 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 110 at risk

Adverse event: Lymphocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 110 at risk

Adverse event: Erythropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 110 at risk

Adverse event: Polycythaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 110 at risk

Adverse event: Trombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 110 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 110 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 110 at risk

Adverse event: Elevated alkaline phosphotase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 27 affected / 110 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 26 affected / 110 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 25 affected / 110 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 110 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 110 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 110 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 110 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 110 at risk

Adverse event: Bradypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 110 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 110 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: non-specified
Frequency: 9 affected / 110 at risk

Adverse event: Elevated urea
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 110 at risk

Adverse event: Elevated creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 110 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 110 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 110 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 110 at risk

Adverse event: Generalized weakness
Serious: no
Organ System: General disorders
Frequency: 25 affected / 110 at risk

Adverse event: Elevated lactate degydrohenase
Serious: no
Organ System: Investigations
Frequency: 32 affected / 110 at risk