Study: NCT00049517

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 257 affected / 328 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 328 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 320 affected / 328 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 328 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 319 affected / 328 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 321 affected / 328 at risk

Adverse event: Transfusion platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 199 affected / 328 at risk

Adverse event: Transfusion: PRBCS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 197 affected / 328 at risk

Adverse event: Hematologic-other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 328 at risk

Adverse event: VOD
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 328 at risk

Adverse event: Supraventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 328 at risk

Adverse event: Ventricular arrthhmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 328 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 328 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 328 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 328 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 328 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 328 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 22 affected / 328 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 328 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 328 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 328 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 328 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 328 at risk

Adverse event: Wound-infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 328 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Psychiatric disorders
Frequency: 26 affected / 328 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 328 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 328 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 328 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 328 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 328 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 328 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 328 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 328 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 328 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 328 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 328 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 328 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 121 affected / 328 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 328 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 328 at risk

Adverse event: Troponin I
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 328 at risk

Adverse event: Operative Injury of Vein/Artery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 328 at risk

Adverse event: Pericardial Effusion/Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 328 at risk

Adverse event: Cardiac-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 328 at risk

Adverse event: Constitutional symptoms
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 328 at risk

Adverse event: PTT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 328 at risk

Adverse event: Hand-Foot Reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 328 at risk

Adverse event: Skin- Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 328 at risk

Adverse event: Inappropriate antidiuretic hormone secretion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 328 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 328 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 328 at risk

Adverse event: Diarrhea w/ prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 328 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 328 at risk

Adverse event: Hemorrhage with Grade 3 or 4 Platelets
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 30 affected / 328 at risk

Adverse event: CNS hemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 328 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 328 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 328 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 328 at risk

Adverse event: Hemorrhage Associated with Surgery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 328 at risk

Adverse event: Petechiae
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 328 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 328 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 328 at risk

Adverse event: Hemorrhage-Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 328 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 328 at risk

Adverse event: Infection w/ Gr3-4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 154 affected / 328 at risk

Adverse event: Catheter-Related Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 328 at risk

Adverse event: Infection w/ unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 328 at risk

Adverse event: Infection w/o neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 328 at risk

Adverse event: Infection- Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 328 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 328 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 328 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 328 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 328 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 328 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 328 at risk

Adverse event: Joint, Muscle, Bone-Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 328 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 328 at risk

Adverse event: Dizziness/Lightheadedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 328 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 328 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 328 at risk

Adverse event: Anxiety/Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 328 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 328 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 328 at risk

Adverse event: Speech Impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 328 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 328 at risk

Adverse event: Ocular-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 328 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 328 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 328 at risk

Adverse event: Bone, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 328 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 328 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 328 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 328 at risk

Adverse event: Rectal or Perirectal Pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 328 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 328 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 328 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 328 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 328 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 328 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 328 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 328 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 328 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 328 at risk

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 328 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 319 affected / 328 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 281 affected / 328 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 243 affected / 328 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 295 affected / 328 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 16 affected / 328 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 328 at risk

Adverse event: Bone Marrow Cellularity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 325 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 251 affected / 325 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 323 affected / 325 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 325 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 305 affected / 325 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 321 affected / 325 at risk

Adverse event: Transfusion platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 206 affected / 325 at risk

Adverse event: Transfusion: PRBCS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 191 affected / 325 at risk

Adverse event: VOD
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 325 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 325 at risk

Adverse event: Supraventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 325 at risk

Adverse event: Ventricular arrthhmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 325 at risk

Adverse event: Arrhythmia-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 325 at risk

Adverse event: Capillary leak syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 325 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 325 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 325 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 325 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 325 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 325 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 29 affected / 325 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 325 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 325 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 325 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 325 at risk

Adverse event: Wound-infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Psychiatric disorders
Frequency: 32 affected / 325 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 325 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 325 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 325 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 20 affected / 325 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 325 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 325 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 325 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 325 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 325 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 325 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 325 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 117 affected / 325 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 325 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 325 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 325 at risk

Adverse event: Cardiac-Left Ventricular Function
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 325 at risk

Adverse event: Cardiac-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 325 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 325 at risk

Adverse event: Wound - non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 325 at risk

Adverse event: Hot flush
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 325 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 325 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 325 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 325 at risk

Adverse event: Diarrhea w/ prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 325 at risk

Adverse event: Hemorrhage with Grade 3 or 4 Platelets
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 36 affected / 325 at risk

Adverse event: Hemorrhage without Grade 3 or 4 Platelets
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 325 at risk

Adverse event: CNS hemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 325 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 325 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 325 at risk

Adverse event: Hemorrhage Associated with Surgery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 325 at risk

Adverse event: Melena/GI Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 325 at risk

Adverse event: Petechiae
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 325 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 325 at risk

Adverse event: Hemorrhage-Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 325 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 325 at risk

Adverse event: Infection w/ Gr3-4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 168 affected / 325 at risk

Adverse event: Catheter-Related Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 325 at risk

Adverse event: Infection w/ unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Infection w/o neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 325 at risk

Adverse event: Infection- Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 325 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 325 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 325 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 325 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 325 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 325 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 325 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 325 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 325 at risk

Adverse event: Anxiety/Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 325 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 325 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 325 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 325 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 325 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 325 at risk

Adverse event: Bone, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 325 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 325 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 325 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 325 at risk

Adverse event: Rectal or Perirectal Pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 325 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 325 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 325 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 325 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 325 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 325 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 325 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 325 at risk

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 325 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 318 affected / 325 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 267 affected / 325 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 230 affected / 325 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 292 affected / 325 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 18 affected / 325 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 325 at risk