Study: NCT00003389

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 414 at risk

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 138 affected / 414 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 175 affected / 414 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 313 affected / 414 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 414 at risk

Adverse event: Transfusion: pRBCs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 414 at risk

Adverse event: Conduction abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 414 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 414 at risk

Adverse event: Cardiac-left ventricular function
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 414 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 414 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 414 at risk

Adverse event: Cardiac-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 414 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 414 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 414 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 414 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 414 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 414 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 414 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 414 at risk

Adverse event: Endocrine-other
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 414 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 414 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 414 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 414 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 414 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 414 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 414 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 414 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 414 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 414 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 414 at risk

Adverse event: Infection w/ grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 23 affected / 414 at risk

Adverse event: Infection w/ unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 414 at risk

Adverse event: Infection w/o neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 414 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 414 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 414 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 414 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 414 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 414 at risk

Adverse event: Dizziness/lightheadedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 414 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 414 at risk

Adverse event: Anxiety/agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 414 at risk

Adverse event: Neuropathy-cranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 414 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 414 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 414 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 414 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 414 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 414 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 414 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 414 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 414 at risk

Adverse event: Dysmenorrhoea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 414 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 414 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 414 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 414 at risk

Adverse event: (DLCO) decreased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 414 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 414 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 414 at risk

Adverse event: Hiccoughs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 414 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 414 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 414 at risk

Adverse event: Pulmonary-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 414 at risk

Adverse event: Incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 414 at risk

Adverse event: Renal/GU-other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 414 at risk

Adverse event: Irregular menses
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 414 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 414 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 374 affected / 414 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Investigations
Frequency: 378 affected / 414 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 319 affected / 414 at risk

Adverse event: Neutrophils decreased
Serious: no
Organ System: Investigations
Frequency: 341 affected / 414 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 118 affected / 414 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 414 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 414 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 320 affected / 414 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 62 affected / 414 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 28 affected / 414 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 41 affected / 414 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 414 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 414 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 287 affected / 414 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 52 affected / 414 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 414 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 414 at risk

Adverse event: Radiation dermatitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 414 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 46 affected / 414 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 30 affected / 414 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 83 affected / 414 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 195 affected / 414 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 414 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 414 at risk

Adverse event: Dysphagia-esophageal radiation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 414 at risk

Adverse event: Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 414 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 313 affected / 414 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 138 affected / 414 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 54 affected / 414 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 191 affected / 414 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 75 affected / 414 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 156 affected / 414 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 414 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 187 affected / 414 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 115 affected / 414 at risk

Adverse event: Infection w/o neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 83 affected / 414 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 192 affected / 414 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 51 affected / 414 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 414 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 414 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 67 affected / 414 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 414 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 34 affected / 414 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 414 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 196 affected / 414 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 414 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 45 affected / 414 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 78 affected / 414 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 34 affected / 414 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 72 affected / 414 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 134 affected / 414 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 32 affected / 414 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 117 affected / 414 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 110 affected / 414 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 414 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 414 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 422 at risk

Adverse event: Allergy-other
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 422 at risk

Adverse event: Middle ear/hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 422 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 86 affected / 422 at risk

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 230 affected / 422 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 328 affected / 422 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 293 affected / 422 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 422 at risk

Adverse event: Transfusion: pRBCs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 422 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 422 at risk

Adverse event: Supraventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 422 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 422 at risk

Adverse event: Cardiac-left ventricular function
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 422 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 422 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 422 at risk

Adverse event: Pericardial effusion/pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 422 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 422 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 422 at risk

Adverse event: Cardiac-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 422 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 422 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 422 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 422 at risk

Adverse event: Coagulation-other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 422 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 422 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 422 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 422 at risk

Adverse event: Radiation dermatitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 422 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 422 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 422 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 422 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 422 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 422 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 422 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 422 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 422 at risk

Adverse event: Dysphagia-esophageal radiation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 422 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 422 at risk

Adverse event: Mucositis due to radiation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 422 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 422 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 422 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 422 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Melena/GI bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 422 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 422 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 422 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 422 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 422 at risk

Adverse event: Catheter-related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 422 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 422 at risk

Adverse event: Infection w/ grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 27 affected / 422 at risk

Adverse event: Infection w/ unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 422 at risk

Adverse event: Infection w/o neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 422 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 422 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 422 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 422 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 422 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 422 at risk

Adverse event: Delusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 422 at risk

Adverse event: Dizziness/lightheadedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 422 at risk

Adverse event: Extrapyramidal movement
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 422 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 422 at risk

Adverse event: Anxiety/agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 422 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 422 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 24 affected / 422 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 39 affected / 422 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 422 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 422 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 422 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 422 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 422 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 422 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 422 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 422 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 422 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 422 at risk

Adverse event: Pain due to radiation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 422 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 422 at risk

Adverse event: (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 422 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 422 at risk

Adverse event: FEV1 decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 422 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 422 at risk

Adverse event: Voice changes/stridor
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 422 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 422 at risk

Adverse event: Urinary frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 422 at risk

Adverse event: Irregular menses
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 422 at risk

Adverse event: Male infertility
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 422 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 422 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 412 affected / 422 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Investigations
Frequency: 394 affected / 422 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 379 affected / 422 at risk

Adverse event: Neutrophils decreased
Serious: no
Organ System: Investigations
Frequency: 354 affected / 422 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 116 affected / 422 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 422 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 35 affected / 422 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 311 affected / 422 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 57 affected / 422 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 39 affected / 422 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 422 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 47 affected / 422 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 422 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 318 affected / 422 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 37 affected / 422 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 422 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 422 at risk

Adverse event: Radiation dermatitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 44 affected / 422 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 53 affected / 422 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 422 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 66 affected / 422 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 221 affected / 422 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 86 affected / 422 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 82 affected / 422 at risk

Adverse event: Dysphagia-esophageal radiation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 422 at risk

Adverse event: Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 422 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 283 affected / 422 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 145 affected / 422 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 47 affected / 422 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 135 affected / 422 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 422 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 108 affected / 422 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 35 affected / 422 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 194 affected / 422 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 111 affected / 422 at risk

Adverse event: Infection w/o neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 422 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 255 affected / 422 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 422 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 422 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 422 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 140 affected / 422 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 46 affected / 422 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 422 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 65 affected / 422 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 329 affected / 422 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 422 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 69 affected / 422 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 422 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 35 affected / 422 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 79 affected / 422 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 168 affected / 422 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 35 affected / 422 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 59 affected / 422 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 95 affected / 422 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 422 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 31 affected / 422 at risk