Study: NCT00404092

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: intermittant ear pressure
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 9 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 9 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 9 at risk

Adverse event: fall, knocked head
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: heart-trouble
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 9 at risk

Adverse event: Hypotonia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vertigo
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: gain of weight
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: hardening of arm/leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 9 at risk

Adverse event: redness at puncture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Erythema of eyelid
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: pain during swallowing
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: swallow pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: bleeding at puncture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Petechiae
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

Adverse event: high ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 9 at risk

Adverse event: high AP
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 9 at risk

Adverse event: high AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 9 at risk

Adverse event: high billirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 9 at risk

Adverse event: high gGT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 9 at risk

Adverse event: high GPT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 9 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 9 at risk

Adverse event: fever in neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: high creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: swelling of arm/leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hallucination
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: intermittant sleep disturbance
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: ague
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: neck aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: pain left upper arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: pain on central venous catheder punction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: pain stomach left site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: pain while breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Worsening of general condition
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Urinary bladder tamponade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 8 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: circulatory discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: collaps
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cyanosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: tightness in the chest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vertigo
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: thrombosis left leg
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: fatique
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nasal dryness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: frequent dejection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: redness at puncture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: redness on backside
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: swelling of arm/leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Tongue coated
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Lip dry
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: bloody sputum
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: haemoptysen
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: hemorrhoids bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 8 at risk

Adverse event: red spots, pustules
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: redness and bleeding of anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: urinary bleeding
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 8 at risk

Adverse event: herpes simplex infection lips
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: high urea
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hyperventilation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 8 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: low protein
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dementia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: prickle and numbness in both feet
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: worsening of visual acuity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: pain in thorax and abdomen
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: pain left calf
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: cough, bloody sputum
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: yellow expectoration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 9 at risk

Adverse event: Persistence or progression of underlying disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: pressure on the ears
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 9 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 9 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: tightness in the chest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vertigo
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: cavernoma left occipital cerebrum
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: croakiness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: hardening of arm/leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: high gammaglobuline/alpha-1-globuline
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 9 at risk

Adverse event: high LDH
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: pruritus at the eyelids
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: reddened hands
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: redness at puncture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 9 at risk

Adverse event: inappetance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: bleeding operation wound left shoulder
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: hematoma at the neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: hematoma left arm
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: hemorrhoids bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Petechiae
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 9 at risk

Adverse event: high AP
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: infection at the puncture of central ven
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: infection of puncture at central venous
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: infection with staphylococcus
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 9 at risk

Adverse event: infection with streptococcus mitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: swelling of the mucosa at the bottom of
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: high uric acid
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: calf cramps
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: viewing of colours
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: neck pain (osteoporosis)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: pain at puncture of the central venous c
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: pain in the left arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: painful peripheral catheter punktion pla
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: pressure pain on the fingernails
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: bronchospasms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: pain int the lungs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: patients feels like he has a common cold
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Syncope
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 20 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Persistence or progression of underlying disease
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 20 at risk

Adverse event: intermittend leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: intermittend thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: persistence of blast cells
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: persistence of blasts
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: cardiac dysrrhthmias
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: collaps
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 20 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: hypotension with dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vertigo
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: fatique
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: perspiration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: aching of the intravenuos line
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 20 at risk

Adverse event: high LDH
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: decubitus ulcer both ears
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: redness at puncture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 20 at risk

Adverse event: swelling of arm/leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: brown coated tongue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 20 at risk

Adverse event: discomfort over the liver area
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: dry mucosa mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: inappetance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: oral lesions due to dental prosthesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: red-brown coated tongue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: yellow coated tongue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: bleeding at puncture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 20 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: hematoma due to blood sampling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Petechiae
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk

Adverse event: red spots at the lower abdominal area
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: elevated bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: elevated liver test (alt)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: high ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 20 at risk

Adverse event: high AP
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 20 at risk

Adverse event: high AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: high direct bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: high gGT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 20 at risk

Adverse event: high total bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: intermittant elevated alt
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: low cholinesterase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: low pancreas amylase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 20 at risk

Adverse event: Herpes virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: high procalcitonin
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: klebsiella detection in sputum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Urethritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 20 at risk

Adverse event: alkaline phophatase increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: elevated uric acid
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: high creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 20 at risk

Adverse event: hypalbuminemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: hypercalcelmia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: hyperchloridemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: hyperglykemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 20 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 20 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hyperventilation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 20 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 20 at risk

Adverse event: intermittant hypoalbuminia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: intermittent hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: low albumin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: low albumine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: low protein
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hallucination
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: intermittend sleeping disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: neuropathia aboth arms
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: paraesthesia (fingers)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: paraesthesia (limbs, lips, fingers)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: patient not addressable
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: slight drowsiness during caspofungin inf
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: small pupils
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: reddened eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: bonepain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Flank pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: kneepain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: neck ache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: pain at the costal arch
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: painful shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: slight backpain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: local pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Stridor
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: worsening of breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: pollakisuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: reduced urine production
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk