Study: NCT00130533

Adverse event: Gastroenteritis and renal insuficience
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 2
Frequency: 1 affected / 436 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 4 affected / 436 at risk

Adverse event: Worsening of depressive syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 436 at risk

Adverse event: Infection with normal ANC ( Urinary)
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: Neutropenia G 3; Leucopenia G2
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 436 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 5
Frequency: 2 affected / 436 at risk

Adverse event: Hand-foot skin reaction
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 436 at risk

Adverse event: Right renal colic
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 2
Frequency: 1 affected / 436 at risk

Adverse event: Mucositis Oral cavity and Pharynx
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: Thorax and left arm pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 436 at risk

Adverse event: Thrombosis/thrombus/embolism: venous thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: Ischemia cardiac/Infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: Axillary nodular resection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 436 at risk

Adverse event: Coronary vasospam
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: Diarrhea grade 2, Vomiting grade 2, Septic shock grade 5
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: Febrile neutropenia, Diarrhea, Hand foot skin reaction, Acute renal failure
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: Hyperbilirrubinemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 1 affected / 436 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 1 affected / 436 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 3 affected / 436 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 19 affected / 436 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 40 affected / 436 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 4
Frequency: 1 affected / 436 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 4
Frequency: 1 affected / 436 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 14 affected / 436 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 45 affected / 436 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 94 affected / 436 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 4
Frequency: 1 affected / 436 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 8 affected / 436 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 74 affected / 436 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 4
Frequency: 1 affected / 436 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: URIC ACID, SERUM-HIGH
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 7 affected / 436 at risk

Adverse event: IRREGULAR MENSES
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 3
Frequency: 57 affected / 436 at risk

Adverse event: IRREGULAR MENSES
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 2
Frequency: 7 affected / 436 at risk

Adverse event: IRREGULAR MENSES
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 1
Frequency: 5 affected / 436 at risk

Adverse event: RASH: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 82 affected / 436 at risk

Adverse event: RASH: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 109 affected / 436 at risk

Adverse event: RASH: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 115 affected / 436 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 54 affected / 436 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 81 affected / 436 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 8 affected / 436 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 50 affected / 436 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 67 affected / 436 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 13 affected / 436 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 48 affected / 436 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 111 affected / 436 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 19 affected / 436 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 87 affected / 436 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 4 affected / 436 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 15 affected / 436 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 84 affected / 436 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 436 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 15 affected / 436 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 69 affected / 436 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 3 affected / 436 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 13 affected / 436 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 50 affected / 436 at risk

Adverse event: Thoracic pain grade 2, disnea G-1
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 425 at risk

Adverse event: Positive pregnant test performed
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 425 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 2
Frequency: 1 affected / 425 at risk

Adverse event: Infarction and cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 425 at risk

Adverse event: Infection with unknown ANC pulmonary/upper respiratory - lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Notes: Grade 5
Frequency: 1 affected / 425 at risk

Adverse event: Showed lumbar column fracture(L4)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 425 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 425 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 6 affected / 425 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 26 affected / 425 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 2 affected / 425 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 4 affected / 425 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 23 affected / 425 at risk

Adverse event: URIC ACID, SERUM-HIGH
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 4
Frequency: 1 affected / 425 at risk

Adverse event: URIC ACID, SERUM-HIGH
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 4 affected / 425 at risk

Adverse event: IRREGULAR MENSES
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 3
Frequency: 55 affected / 425 at risk

Adverse event: IRREGULAR MENSES
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 2
Frequency: 6 affected / 425 at risk

Adverse event: IRREGULAR MENSES
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 1
Frequency: 6 affected / 425 at risk

Adverse event: RASH: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 1 affected / 425 at risk

Adverse event: RASH: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 2 affected / 425 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 12 affected / 425 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 46 affected / 425 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 8 affected / 425 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 38 affected / 425 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 10 affected / 425 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 38 affected / 425 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 27 affected / 425 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 6 affected / 425 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 1 affected / 425 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 27 affected / 425 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 425 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 3 affected / 425 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 21 affected / 425 at risk