Study: NCT00326898

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 625 at risk

Adverse event: Hearing w/o audiogr not in monitor prg
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 625 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 625 at risk

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 625 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 625 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 625 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 625 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 625 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 625 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 625 at risk

Adverse event: Extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 625 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 625 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 104 affected / 625 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 625 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 625 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 108 affected / 625 at risk

Adverse event: Fever w/o neutropenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 625 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 625 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 625 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 94 affected / 625 at risk

Adverse event: Hyopthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 625 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 625 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 625 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 625 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 625 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 625 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 625 at risk

Adverse event: Muco/stomatitis (symptom) pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 625 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 625 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 625 at risk

Adverse event: Colon, hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 625 at risk

Adverse event: Stomach, hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Kidney, hemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 625 at risk

Adverse event: Nose, hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 625 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 625 at risk

Adverse event: Liver dysfunction/failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 625 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 625 at risk

Adverse event: Hepatic-other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 625 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 625 at risk

Adverse event: Infection w/ gr3-4 neut, ileum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Infection Gr0-2 neut, kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Infection Gr0-2 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 625 at risk

Adverse event: Infection Gr0-2 neut, nerve-cranial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Infection Gr0-2 neut, vagina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Infection Gr0-2 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Infection-other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Edema head and neck
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 625 at risk

Adverse event: Edema limb
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 625 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 625 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 625 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 625 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 625 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 625 at risk

Adverse event: Hypercholesterolaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 625 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 625 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 625 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 625 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 625 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 625 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 625 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 625 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 625 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 625 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 625 at risk

Adverse event: Nonneuropathic upper extr muscle weak
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 625 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 625 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 625 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 625 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 625 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 625 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 625 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 625 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 625 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 625 at risk

Adverse event: Back, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Bone, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 625 at risk

Adverse event: Cardiac/heart, pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 625 at risk

Adverse event: Chest/thoracic pain NOS
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 625 at risk

Adverse event: Esophagus, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Extremity-limb, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 625 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 625 at risk

Adverse event: Joint, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 625 at risk

Adverse event: Muscle, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 625 at risk

Adverse event: Oral cavity, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 625 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 625 at risk

Adverse event: Flu-like syndrome
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 625 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 625 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 38 affected / 625 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 62 affected / 625 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 625 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 625 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 625 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 625 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 628 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 628 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 628 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 628 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 96 affected / 628 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 628 at risk

Adverse event: Cor pulmonale
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 628 at risk

Adverse event: cardiac-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 628 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 41 affected / 628 at risk

Adverse event: Fever w/o neutropenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 628 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 628 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 628 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 628 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 93 affected / 628 at risk

Adverse event: Rash: acne/acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 628 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 628 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 208 affected / 628 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 628 at risk

Adverse event: Wound - non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 628 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 628 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 628 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 628 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 628 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 628 at risk

Adverse event: Distention/bloating, abdominal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 628 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Muco/stomatitis (symptom) pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 628 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 628 at risk

Adverse event: Perforation, colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 628 at risk

Adverse event: Lower GI, hemorrhage NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Infection Gr0-2 neut, colon
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 628 at risk

Adverse event: Infection Gr0-2 neut, kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 628 at risk

Adverse event: Infection Gr0-2 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 628 at risk

Adverse event: Infection Gr0-2 neut, mucosa
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 628 at risk

Adverse event: Infection Gr0-2 neut, muscle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 628 at risk

Adverse event: Infection Gr0-2 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 628 at risk

Adverse event: Infection Gr0-2 neut, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 628 at risk

Adverse event: Infection w/ unk ANC skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 628 at risk

Adverse event: Infection w/ unk ANC urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 628 at risk

Adverse event: Infection-other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 628 at risk

Adverse event: Edema head and neck
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 628 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 628 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 628 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 628 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 628 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 628 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 628 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 628 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 628 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 628 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 628 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 628 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 628 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 628 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 628 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 628 at risk

Adverse event: Nonneuropathic left-side muscle weak
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 628 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 628 at risk

Adverse event: Musculoskeletal/soft tissue-other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 628 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 628 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 628 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 628 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 628 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 628 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 628 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 628 at risk

Adverse event: Ocular-other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 628 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 628 at risk

Adverse event: Back, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 628 at risk

Adverse event: Bone, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 628 at risk

Adverse event: Cardiac/heart, pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 628 at risk

Adverse event: Chest/thoracic pain NOS
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 628 at risk

Adverse event: Extremity-limb, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 628 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 628 at risk

Adverse event: Joint, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 628 at risk

Adverse event: Muscle, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 628 at risk

Adverse event: Oral cavity, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Scalp, pain
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 628 at risk

Adverse event: Skin, pain
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 628 at risk

Adverse event: Stomach, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 628 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 628 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Voice changes/dysarthria
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 628 at risk

Adverse event: Renal/GU-other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 628 at risk

Adverse event: Secondary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 628 at risk

Adverse event: Sexual/Reproductive function-Other
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 628 at risk

Adverse event: Vascular access,Thrombosis/embolism
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 628 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 628 at risk

Adverse event: Vascular-Other (Specify)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 628 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 38 affected / 628 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 58 affected / 628 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 628 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 52 affected / 628 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 628 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 628 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 626 at risk

Adverse event: Heart block abnormality NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 626 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 626 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 626 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 626 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 626 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 626 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 626 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 626 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 626 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 626 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 626 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 626 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 626 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 626 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 626 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 626 at risk

Adverse event: Infection Gr0-2 neut, appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 626 at risk

Adverse event: Infection Gr0-2 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 626 at risk

Adverse event: Infection Gr0-2 neut, mediastinm
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 626 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 626 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 626 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 626 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 626 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 626 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 626 at risk

Adverse event: Nonneuropathic right-side muscle weak
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 626 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 626 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 626 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 626 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 626 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 626 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 626 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 626 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 626 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 626 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 626 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 626 at risk

Adverse event: Joint, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 626 at risk

Adverse event: Muscle, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 626 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 626 at risk

Adverse event: Secondary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 626 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 626 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 626 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 31 affected / 626 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 626 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 626 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 626 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 626 at risk