Study: NCT00014222

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 680 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 49 affected / 680 at risk

Adverse event: Oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 680 at risk

Adverse event: Keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 680 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 680 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 680 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 680 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 680 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 680 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 680 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 680 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 680 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 680 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 680 at risk

Adverse event: Rigors, chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 680 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 680 at risk

Adverse event: Pain-Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 680 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 680 at risk

Adverse event: Other
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 680 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 680 at risk

Adverse event: Other
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 680 at risk

Adverse event: Granulocytes
Serious: yes
Organ System: Investigations
Frequency: 18 affected / 680 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 680 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 680 at risk

Adverse event: SGOT (AST)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 680 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 680 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 680 at risk

Adverse event: Mouth dryness
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 680 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 680 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 680 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 680 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 680 at risk

Adverse event: Secondary Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 680 at risk

Adverse event: CNS hemorrhage/bleed
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 680 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 680 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 680 at risk

Adverse event: Seizure(s)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 680 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 680 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 680 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 680 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 680 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 680 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 680 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 680 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 680 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 680 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 680 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 680 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 680 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 680 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 112 affected / 680 at risk

Adverse event: Cardiac LVF
Serious: no
Organ System: Cardiac disorders
Frequency: 185 affected / 680 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 680 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 32 affected / 680 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 67 affected / 680 at risk

Adverse event: Tearing
Serious: no
Organ System: Eye disorders
Frequency: 122 affected / 680 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 415 affected / 680 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 321 affected / 680 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 135 affected / 680 at risk

Adverse event: Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 680 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 278 affected / 680 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 583 affected / 680 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 82 affected / 680 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 554 affected / 680 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 369 affected / 680 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 680 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 78 affected / 680 at risk

Adverse event: Rectal/perirectal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 680 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 643 affected / 680 at risk

Adverse event: Rigors, chills
Serious: no
Organ System: General disorders
Frequency: 56 affected / 680 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 37 affected / 680 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 151 affected / 680 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 130 affected / 680 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 106 affected / 680 at risk

Adverse event: Infection w/o neutropen
Serious: no
Organ System: Infections and infestations
Frequency: 181 affected / 680 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 156 affected / 680 at risk

Adverse event: Wound-infectious
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 680 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 680 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 323 affected / 680 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 38 affected / 680 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 680 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 241 affected / 680 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 262 affected / 680 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 100 affected / 680 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 205 affected / 680 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 218 affected / 680 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 680 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 680 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 179 affected / 680 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 229 affected / 680 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 680 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 117 affected / 680 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 181 affected / 680 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 100 affected / 680 at risk

Adverse event: Urine frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 32 affected / 680 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 49 affected / 680 at risk

Adverse event: Irregular menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 290 affected / 680 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 45 affected / 680 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 104 affected / 680 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 147 affected / 680 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 297 affected / 680 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 49 affected / 680 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 635 affected / 680 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 61 affected / 680 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 680 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 104 affected / 680 at risk

Adverse event: Pigmentation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 680 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 680 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 158 affected / 680 at risk

Adverse event: Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 680 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 680 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 52 affected / 680 at risk

Adverse event: Hot flashes/ flushes
Serious: no
Organ System: Vascular disorders
Frequency: 435 affected / 680 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 680 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 688 at risk

Adverse event: Transfusion: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 688 at risk

Adverse event: Transfusion: pRBCs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 688 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 41 affected / 688 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 688 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 688 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 688 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 688 at risk

Adverse event: Dyspepsia/heartburn
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 688 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 688 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 688 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 688 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 688 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 688 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 688 at risk

Adverse event: Rigors, chills
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 688 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 688 at risk

Adverse event: Pain-Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 688 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 688 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 688 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Immune system disorders
Frequency: 8 affected / 688 at risk

Adverse event: Other
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 688 at risk

Adverse event: Other
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 688 at risk

Adverse event: Catheter-related infect
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 688 at risk

Adverse event: Wound-infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 688 at risk

Adverse event: Granulocytes
Serious: yes
Organ System: Investigations
Frequency: 16 affected / 688 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 14 affected / 688 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 688 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 688 at risk

Adverse event: SGPT (ALT)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 688 at risk

Adverse event: SGOT (AST)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 688 at risk

Adverse event: Blood bilirubin
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 688 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 688 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 688 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 688 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 688 at risk

Adverse event: Secondary Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 688 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 688 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 688 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 688 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 688 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 688 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 688 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 688 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 688 at risk

Adverse event: Gynaecomastia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 688 at risk

Adverse event: Vaginal infection
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 688 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 688 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 688 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 688 at risk

Adverse event: Hand-foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 688 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 688 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 688 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 688 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 688 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 688 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 108 affected / 688 at risk

Adverse event: Cardiac LVF
Serious: no
Organ System: Cardiac disorders
Frequency: 147 affected / 688 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 45 affected / 688 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 56 affected / 688 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 80 affected / 688 at risk

Adverse event: Tearing
Serious: no
Organ System: Eye disorders
Frequency: 186 affected / 688 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 442 affected / 688 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 400 affected / 688 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 163 affected / 688 at risk

Adverse event: Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 101 affected / 688 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 242 affected / 688 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 636 affected / 688 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 95 affected / 688 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 554 affected / 688 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 499 affected / 688 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 688 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 93 affected / 688 at risk

Adverse event: Rectal/perirectal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 688 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 649 affected / 688 at risk

Adverse event: Rigors, chills
Serious: no
Organ System: General disorders
Frequency: 67 affected / 688 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 51 affected / 688 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 198 affected / 688 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 162 affected / 688 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 170 affected / 688 at risk

Adverse event: Infection w/o neutropen
Serious: no
Organ System: Infections and infestations
Frequency: 234 affected / 688 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 113 affected / 688 at risk

Adverse event: Wound-infectious
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 688 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 68 affected / 688 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 431 affected / 688 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 56 affected / 688 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 57 affected / 688 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 497 affected / 688 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 521 affected / 688 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 235 affected / 688 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 269 affected / 688 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 265 affected / 688 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 688 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 63 affected / 688 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 499 affected / 688 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 308 affected / 688 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 50 affected / 688 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 151 affected / 688 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 218 affected / 688 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 129 affected / 688 at risk

Adverse event: Urine frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 39 affected / 688 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 56 affected / 688 at risk

Adverse event: Irregular menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 352 affected / 688 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 52 affected / 688 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 205 affected / 688 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 231 affected / 688 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 320 affected / 688 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 66 affected / 688 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 641 affected / 688 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 89 affected / 688 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 106 affected / 688 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 310 affected / 688 at risk

Adverse event: Pigmentation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 52 affected / 688 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 688 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 202 affected / 688 at risk

Adverse event: Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 47 affected / 688 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 42 affected / 688 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 46 affected / 688 at risk

Adverse event: Hot flashes/ flushes
Serious: no
Organ System: Vascular disorders
Frequency: 467 affected / 688 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 45 affected / 688 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 675 at risk

Adverse event: Ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 675 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 675 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 675 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 675 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 675 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 675 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 675 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 675 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 675 at risk

Adverse event: Rigors, chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 675 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 675 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 675 at risk

Adverse event: Other
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 675 at risk

Adverse event: Wound-infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 675 at risk

Adverse event: Granulocytes
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 675 at risk

Adverse event: Troponin T
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 675 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 675 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 675 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 675 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 675 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 675 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 675 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 675 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 675 at risk

Adverse event: Hyperhidrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 675 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 675 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 675 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 51 affected / 675 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 110 affected / 675 at risk

Adverse event: Cardiac LVF
Serious: no
Organ System: Cardiac disorders
Frequency: 130 affected / 675 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 36 affected / 675 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 46 affected / 675 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 81 affected / 675 at risk

Adverse event: Tearing
Serious: no
Organ System: Eye disorders
Frequency: 145 affected / 675 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 395 affected / 675 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 273 affected / 675 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 98 affected / 675 at risk

Adverse event: Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 675 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 207 affected / 675 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 601 affected / 675 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 675 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 431 affected / 675 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 353 affected / 675 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 675 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 97 affected / 675 at risk

Adverse event: Rectal/perirectal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 675 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 621 affected / 675 at risk

Adverse event: Rigors, chills
Serious: no
Organ System: General disorders
Frequency: 42 affected / 675 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 36 affected / 675 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 171 affected / 675 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 70 affected / 675 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 79 affected / 675 at risk

Adverse event: Infection w/o neutropen
Serious: no
Organ System: Infections and infestations
Frequency: 162 affected / 675 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 675 at risk

Adverse event: Wound-infectious
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 675 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 675 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 296 affected / 675 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 675 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 48 affected / 675 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 457 affected / 675 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 500 affected / 675 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 122 affected / 675 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 202 affected / 675 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 185 affected / 675 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 675 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 675 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 474 affected / 675 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 266 affected / 675 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 675 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 156 affected / 675 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 199 affected / 675 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 101 affected / 675 at risk

Adverse event: Urine frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 675 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 38 affected / 675 at risk

Adverse event: Irregular menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 269 affected / 675 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 36 affected / 675 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 171 affected / 675 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 177 affected / 675 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 241 affected / 675 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 64 affected / 675 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 636 affected / 675 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 58 affected / 675 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 675 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 100 affected / 675 at risk

Adverse event: Pigmentation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 675 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 675 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 156 affected / 675 at risk

Adverse event: Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 675 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 675 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 675 at risk

Adverse event: Hot flashes/ flushes
Serious: no
Organ System: Vascular disorders
Frequency: 470 affected / 675 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 48 affected / 675 at risk