Study: NCT00110019

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 20 affected / 393 at risk

Adverse event: Otitis, middle ear
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 393 at risk

Adverse event: Tinnitus
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 393 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 393 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 393 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 108 affected / 393 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 21 affected / 393 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Frequency: 192 affected / 393 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Frequency: 92 affected / 393 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 393 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 393 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: PVCs
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 393 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 393 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 393 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 63 affected / 393 at risk

Adverse event: Fever w/o neutropenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 393 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 393 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 393 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 393 at risk

Adverse event: activated partial thromboplastin time (PTT)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 393 at risk

Adverse event: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 393 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 393 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 58 affected / 393 at risk

Adverse event: Rash: acne/acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 393 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 47 affected / 393 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Death - multiorgan failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 393 at risk

Adverse event: Death - sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 393 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 393 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 393 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 393 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 393 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Muco/stomatitis (symptom) oral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 393 at risk

Adverse event: Muco/stomatitis (symptom) stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 393 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 393 at risk

Adverse event: Obstruction, small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Perforation, colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 393 at risk

Adverse event: Ulcer, duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 393 at risk

Adverse event: Gastrointestinal disorder-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 393 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 393 at risk

Adverse event: CNS, hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Colon, hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Duodenum, hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 393 at risk

Adverse event: Lower GI, hemorrhage NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Stomach, hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Kidney, hemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 393 at risk

Adverse event: Nose, hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Hemorrhage-other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 393 at risk

Adverse event: Colitis, infectious (e.g. C.diff)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 393 at risk

Adverse event: Infection w/ gr304 neut, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Infection w/ gr304 neut, catheter relate
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Infection w/ gr304 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 393 at risk

Adverse event: Infection w/ gr304 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 393 at risk

Adverse event: Infection w/ gr304 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 393 at risk

Adverse event: Infection Gr002 neut, foreign body
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Infection Gr002 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 393 at risk

Adverse event: Infection Gr002 neut, pharynx
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Infection Gr002 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 393 at risk

Adverse event: Infection Gr002 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Infection Gr002 neut, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Infection w/ unk ANC skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Opportunistic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Infection w/ gr304 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 393 at risk

Adverse event: Infection Gr002 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Infection- other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 393 at risk

Adverse event: Edema limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 393 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 393 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 393 at risk

Adverse event: ALT, SGPT
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 393 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 393 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 393 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 393 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 393 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 393 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 393 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 393 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 393 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 393 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 393 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 393 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 393 at risk

Adverse event: Metabolic/Laboratory-other
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 393 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Joint-function
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Nonneuropathic lower extr muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 393 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 393 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 393 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 393 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 393 at risk

Adverse event: Neuropathy- motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 393 at risk

Adverse event: Neuropathy- sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 81 affected / 393 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 393 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 393 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 393 at risk

Adverse event: Vision photophobia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 393 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 393 at risk

Adverse event: Bone, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 393 at risk

Adverse event: Cardiac/heart, pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Chest wall, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 393 at risk

Adverse event: Chest/thoracic pain NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 393 at risk

Adverse event: Extremity limb, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 393 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 393 at risk

Adverse event: Joint, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 393 at risk

Adverse event: Lymph node, pain
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Muscle, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 393 at risk

Adverse event: Neuropathic, pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Pleura, pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Skin, pain
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Throat/pharynx/larynx, pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 393 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 393 at risk

Adverse event: Hiccoughs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 393 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 393 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 393 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 393 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 393 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 14 affected / 393 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 393 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 393 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 191 affected / 393 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 135 affected / 393 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 38 affected / 393 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 101 affected / 393 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 182 affected / 393 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 87 affected / 393 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 311 affected / 393 at risk

Adverse event: Fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 393 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 47 affected / 393 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 34 affected / 393 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 23 affected / 393 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 62 affected / 393 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 393 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 393 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 202 affected / 393 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 110 affected / 393 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 198 affected / 393 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 119 affected / 393 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 393 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 137 affected / 393 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 101 affected / 393 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 393 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 200 affected / 393 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 393 at risk

Adverse event: Muco/stomatitis (symptom) stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 84 affected / 393 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 206 affected / 393 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 393 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 104 affected / 393 at risk

Adverse event: Nose, hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 393 at risk

Adverse event: Edema limb
Serious: no
Organ System: General disorders
Frequency: 35 affected / 393 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 393 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 46 affected / 393 at risk

Adverse event: Alanine aminotransferase (ALT, SGPT)
Serious: no
Organ System: Investigations
Frequency: 48 affected / 393 at risk

Adverse event: Aspartate aminotransferase (AST, SGOT)
Serious: no
Organ System: Investigations
Frequency: 56 affected / 393 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 58 affected / 393 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 393 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 393 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 393 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 51 affected / 393 at risk

Adverse event: Metabolic/Laboratory-other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 393 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 393 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 262 affected / 393 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 393 at risk

Adverse event: Extremity-limb, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 393 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 393 at risk

Adverse event: Joint, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 157 affected / 393 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 158 affected / 393 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 393 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 65 affected / 393 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 393 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 393 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 11 affected / 397 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 397 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 91 affected / 397 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 17 affected / 397 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Frequency: 195 affected / 397 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Frequency: 35 affected / 397 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 397 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 397 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 397 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 397 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 397 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 397 at risk

Adverse event: cardiac-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 397 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 56 affected / 397 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 397 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 397 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 397 at risk

Adverse event: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 397 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 397 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 397 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 397 at risk

Adverse event: Death - sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 397 at risk

Adverse event: Hot flush
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 397 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 397 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 397 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 397 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 397 at risk

Adverse event: Distention/bloating, abdominal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 397 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Muco/stomatitis (symptom) oral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 397 at risk

Adverse event: Obstruction, small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 397 at risk

Adverse event: Perforation, colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Ulcer, duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 397 at risk

Adverse event: CNS, hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 397 at risk

Adverse event: Abdomen, hemorrhage NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Colon, hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Duodenum, hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 397 at risk

Adverse event: Infection w/ gr304 neut, anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Infection w/ gr304 neut, bladder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Infection w/ gr304 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 397 at risk

Adverse event: Infection w/ gr304 neut, oral cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 397 at risk

Adverse event: Infection w/ gr304 neut, pharynx
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 397 at risk

Adverse event: Infection w/ gr304 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 397 at risk

Adverse event: Infection w/ gr304 neut, upper airway
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Infection w/ gr304 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Infection Gr002 neut, catheter
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Infection Gr002 neut, colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Infection Gr002 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 397 at risk

Adverse event: Infection Gr002 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 397 at risk

Adverse event: Infection Gr002 neut, soft tissue
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Infection Gr002 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Infection w/ unk ANC lung
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 397 at risk

Adverse event: Infection w/ unk ANC mucosa
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Opportunistic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Infection w/ gr304 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 397 at risk

Adverse event: Infection Gr002 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Infection w/ unk ANC blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Infection- other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 397 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 397 at risk

Adverse event: Alkalosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 397 at risk

Adverse event: ALT, SGPT
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 397 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 397 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 397 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 397 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 397 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 397 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 397 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 397 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 397 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 397 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 397 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 397 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 397 at risk

Adverse event: Metabolic/Laboratory-other
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 397 at risk

Adverse event: Nonneuropathic upper extr muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 397 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 397 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 397 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 397 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 397 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 397 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 397 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 397 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 397 at risk

Adverse event: Neuropathy- motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 397 at risk

Adverse event: Neuropathy- sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 59 affected / 397 at risk

Adverse event: Personality
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 397 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 397 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 397 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 397 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 397 at risk

Adverse event: Bone, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 397 at risk

Adverse event: Cardiac/heart, pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 397 at risk

Adverse event: Chest/thoracic pain NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 397 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 397 at risk

Adverse event: Joint, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 397 at risk

Adverse event: Muscle, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 397 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 397 at risk

Adverse event: Pericardium, pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 397 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 397 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 397 at risk

Adverse event: Hiccoughs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 397 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 397 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 397 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 397 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 397 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 397 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 195 affected / 397 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 146 affected / 397 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 29 affected / 397 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 117 affected / 397 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 131 affected / 397 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 38 affected / 397 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 296 affected / 397 at risk

Adverse event: Fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 397 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 39 affected / 397 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 21 affected / 397 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 12 affected / 397 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 397 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 397 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 397 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 209 affected / 397 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 59 affected / 397 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 105 affected / 397 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 397 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 397 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 118 affected / 397 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 86 affected / 397 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 397 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 113 affected / 397 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 397 at risk

Adverse event: Muco/stomatitis (symptom) stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 397 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 230 affected / 397 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 397 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 117 affected / 397 at risk

Adverse event: Nose, hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 397 at risk

Adverse event: Edema limb
Serious: no
Organ System: General disorders
Frequency: 31 affected / 397 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 397 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 397 at risk

Adverse event: Alanine aminotransferase (ALT, SGPT)
Serious: no
Organ System: Investigations
Frequency: 33 affected / 397 at risk

Adverse event: Aspartate aminotransferase (AST, SGOT)
Serious: no
Organ System: Investigations
Frequency: 29 affected / 397 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 397 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 397 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 397 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 397 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 397 at risk

Adverse event: Metabolic/Laboratory-other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 397 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 397 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 265 affected / 397 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 397 at risk

Adverse event: Extremity-limb, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 397 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 397 at risk

Adverse event: Joint, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 151 affected / 397 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 182 affected / 397 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 397 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 397 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 397 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 397 at risk