Study: NCT00432172

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 3 affected / 45 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Acute
Frequency: 1 affected / 45 at risk

Adverse event: Infection pulmonary/ Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 45 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 5 affected / 45 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 1 affected / 45 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 5 affected / 45 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 5 affected / 45 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 2 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 4 affected / 45 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 3 affected / 45 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 3 affected / 45 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 45 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 45 at risk

Adverse event: Irregular menses
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 3
Frequency: 1 affected / 45 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Grade 3
Frequency: 1 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 45 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 45 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 45 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 24 affected / 45 at risk

Adverse event: Hair loss/alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 34 affected / 45 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Notes: Grade 1
Frequency: 4 affected / 45 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 16 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 20 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 7 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 8 affected / 45 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 4
Frequency: 1 affected / 46 at risk

Adverse event: Irregular menses
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 3
Frequency: 8 affected / 46 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 3 affected / 46 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Notes: Grade 1
Frequency: 14 affected / 46 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 9 affected / 46 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 8 affected / 46 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 5 affected / 46 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 5 affected / 46 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 5 affected / 46 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 4
Frequency: 1 affected / 46 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 2 affected / 46 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Infection - Port a cath infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Infection - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Infection - septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Mucositis/stomatitis and Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Mucositis grade 2, Vomiting grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Diabetes decompensation
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 46 at risk

Adverse event: Growth and abcessification of the tumor and cellulitis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 46 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 2 affected / 46 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 2 affected / 46 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 7 affected / 46 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 3 affected / 46 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 7 affected / 46 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 4 affected / 46 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Grade 4
Frequency: 3 affected / 46 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Grade 3
Frequency: 2 affected / 46 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 2 affected / 46 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 4 affected / 46 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 23 affected / 46 at risk

Adverse event: Hair loss/alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 29 affected / 46 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Notes: Grade 1
Frequency: 1 affected / 46 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 7 affected / 46 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 14 affected / 46 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 4 affected / 47 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 3 affected / 47 at risk

Adverse event: Infection with unknown ANC - Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Surgical intervention at left upper extremity
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 47 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 4 affected / 47 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 2 affected / 47 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 4 affected / 47 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 3 affected / 47 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 5 affected / 47 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 5 affected / 47 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 47 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 5 affected / 47 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 47 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Grade 3
Frequency: 1 affected / 47 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 4 affected / 47 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 1 affected / 47 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 3 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 2 affected / 47 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 47 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 3 affected / 47 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 17 affected / 47 at risk

Adverse event: Hair loss/alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 29 affected / 47 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Notes: Grade 1
Frequency: 3 affected / 47 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 7 affected / 47 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 14 affected / 47 at risk