Study: NCT00129935

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 55 affected / 669 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 4
Frequency: 7 affected / 669 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 669 at risk

Adverse event: Infection with grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 8 affected / 669 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 7 affected / 669 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Notes: Grade 4
Frequency: 7 affected / 669 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Notes: Grade 3
Frequency: 5 affected / 669 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 669 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 4
Frequency: 1 affected / 669 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 669 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 669 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 669 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 669 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2
Frequency: 1 affected / 669 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 669 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 2 affected / 669 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 669 at risk

Adverse event: Abdominal pain and hematuria
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 669 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 669 at risk

Adverse event: Hand foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 1 affected / 669 at risk

Adverse event: Breast implant repeled
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 669 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 3 affected / 669 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 669 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 669 at risk

Adverse event: Mood alteration-anxiety agitation
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 669 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 44 affected / 669 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 83 affected / 669 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 108 affected / 669 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 27 affected / 669 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 51 affected / 669 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 126 affected / 669 at risk

Adverse event: IRREGULAR MENSES
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 3
Frequency: 160 affected / 669 at risk

Adverse event: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 14 affected / 669 at risk

Adverse event: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 15 affected / 669 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 562 affected / 669 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 285 affected / 669 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 184 affected / 669 at risk

Adverse event: STOMATITIS/PHARYNGITIS (ORAL/PHARYNGEAL MUCOSITIS)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 154 affected / 669 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 20 affected / 669 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 76 affected / 669 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 84 affected / 669 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 105 affected / 669 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 100 affected / 669 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 2
Frequency: 39 affected / 669 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 125 affected / 669 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2
Frequency: 72 affected / 669 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 70 affected / 669 at risk

Adverse event: INFECTION WITHOUT NEUTROPENIA
Serious: no
Organ System: Immune system disorders
Notes: Grade 2
Frequency: 71 affected / 669 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 68 affected / 669 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2
Frequency: 89 affected / 669 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 40 affected / 715 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 4
Frequency: 2 affected / 715 at risk

Adverse event: Infection with grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 3 affected / 715 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 3 affected / 715 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Notes: Grade 4
Frequency: 7 affected / 715 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Notes: Grade 3
Frequency: 2 affected / 715 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 25 affected / 715 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 3 affected / 715 at risk

Adverse event: Hand foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 2 affected / 715 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 3 affected / 715 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 715 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 4
Frequency: 3 affected / 715 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 715 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 715 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: Mucositis / Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 4
Frequency: 1 affected / 715 at risk

Adverse event: Adenocarcinoma pancreas
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 715 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 4
Frequency: 2 affected / 715 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 1 affected / 715 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: Bone Fracture
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 2 affected / 715 at risk

Adverse event: Cardiac ischemia / infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 4 affected / 715 at risk

Adverse event: Cardiac ischemia / infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 4
Frequency: 1 affected / 715 at risk

Adverse event: Catheter-related infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 1 affected / 715 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 2 affected / 715 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 715 at risk

Adverse event: Pneumonitis/Pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 715 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2
Frequency: 1 affected / 715 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 715 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Grade 1
Frequency: 1 affected / 715 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Immune system disorders
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: Epidermis necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 715 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 2 affected / 715 at risk

Adverse event: Progression disease, carcinomatosis meninges
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 715 at risk

Adverse event: Phenytoin poisoning interaction with capecitabine
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 715 at risk

Adverse event: Ureteral obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 1
Frequency: 1 affected / 715 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: Conduction abnormality/ Atrioventricular heart block
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 715 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 36 affected / 715 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 33 affected / 715 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 91 affected / 715 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 36 affected / 715 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 32 affected / 715 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 66 affected / 715 at risk

Adverse event: IRREGULAR MENSES
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 3
Frequency: 146 affected / 715 at risk

Adverse event: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 139 affected / 715 at risk

Adverse event: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 169 affected / 715 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 569 affected / 715 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 270 affected / 715 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 161 affected / 715 at risk

Adverse event: STOMATITIS/PHARYNGITIS (ORAL/PHARYNGEAL MUCOSITIS)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 115 affected / 715 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 73 affected / 715 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 118 affected / 715 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 74 affected / 715 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 73 affected / 715 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 81 affected / 715 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 2
Frequency: 94 affected / 715 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 122 affected / 715 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2
Frequency: 34 affected / 715 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 59 affected / 715 at risk

Adverse event: INFECTION WITHOUT NEUTROPENIA
Serious: no
Organ System: Immune system disorders
Notes: Grade 2
Frequency: 61 affected / 715 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 62 affected / 715 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2
Frequency: 42 affected / 715 at risk