Study: NCT02103439

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 38 affected / 70 at risk

Adverse event: Asthenia (weakness, fatigue)
Serious: no
Organ System: General disorders
Frequency: 17 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 70 at risk

Adverse event: Irritability, emotional lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 70 at risk

Adverse event: Sleep disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 70 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 70 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 70 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 70 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 70 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 70 at risk

Adverse event: Skin itch
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 70 at risk

Adverse event: Skin redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 70 at risk

Adverse event: Skin dryness and exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 70 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 60 affected / 70 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 53 affected / 70 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 43 affected / 70 at risk

Adverse event: Decreased level of CD4+ lymphocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 70 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 39 affected / 70 at risk

Adverse event: Need in filgrastim
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 70 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 49 affected / 70 at risk

Adverse event: Need in Rebetol dose correction due to anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 70 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 22 affected / 70 at risk

Adverse event: Bilirubin conjugated increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 31 affected / 70 at risk

Adverse event: Increased albumin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 16 affected / 70 at risk

Adverse event: Increased alanine aminotranferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 25 affected / 70 at risk

Adverse event: Increased aspartate aminotranferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 28 affected / 70 at risk

Adverse event: Increased gamma glumamyltransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 21 affected / 70 at risk

Adverse event: Increased alkaline phosphotase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 70 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 70 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 10 affected / 70 at risk

Adverse event: Increased triglycerides
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 70 at risk

Adverse event: Increased cholesterol
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 70 at risk

Adverse event: Increased thyroid stimulating hormone
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 70 at risk

Adverse event: Increased creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 70 at risk

Adverse event: Hyperaemia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 70 at risk

Adverse event: CTCAE 4.03 Grade 4 anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 71 at risk

Adverse event: cavitary pulmonary tuberculosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 41 affected / 71 at risk

Adverse event: Asthenia (weakness, fatigue)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 71 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 71 at risk

Adverse event: Irritability, emotional lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 71 at risk

Adverse event: Sleep disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 71 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 71 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 71 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 71 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 71 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 71 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 71 at risk

Adverse event: Skin itch
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 71 at risk

Adverse event: Skin redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Skin dryness and exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 71 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 59 affected / 71 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 51 affected / 71 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 55 affected / 71 at risk

Adverse event: Decreased level of CD4+ lymphocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 71 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 36 affected / 71 at risk

Adverse event: Need in filgrastim
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 71 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 57 affected / 71 at risk

Adverse event: Need in Rebetol dose correction due to anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 71 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 26 affected / 71 at risk

Adverse event: Bilirubin conjugated increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 31 affected / 71 at risk

Adverse event: Increased albumin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 25 affected / 71 at risk

Adverse event: Increased alanine aminotranferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 18 affected / 71 at risk

Adverse event: Increased aspartate aminotranferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 29 affected / 71 at risk

Adverse event: Increased gamma glumamyltransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 31 affected / 71 at risk

Adverse event: Increased alkaline phosphotase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 71 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 71 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 14 affected / 71 at risk

Adverse event: Increased triglycerides
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 71 at risk

Adverse event: Increased cholesterol
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 71 at risk

Adverse event: Increased thyroid stimulating hormone
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 71 at risk

Adverse event: Increased creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 71 at risk

Adverse event: Hyperaemia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 71 at risk