Study: NCT00550537

Adverse event: Infection (urinary tract)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Infection (pharynx)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Rash (allergy)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Infection (port)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Pulmonary (other)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Procedural pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: worsening pneumothorax and subcutaneous emphysema.
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 116 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 116 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 116 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 29 affected / 116 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 116 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 116 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 116 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 116 at risk

Adverse event: Rash (acne/acneiform)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 55 affected / 116 at risk

Adverse event: Rash (desquamation)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 40 affected / 116 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 116 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 116 at risk

Adverse event: Dermatology/Skin (other)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 116 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 116 at risk

Adverse event: Fatigue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 116 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Eye disorders
Frequency: 22 affected / 116 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 10 affected / 116 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 116 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 116 at risk

Adverse event: Limb pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 116 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 116 at risk

Adverse event: Check pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 116 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 116 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 116 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 116 at risk

Adverse event: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 116 at risk

Adverse event: Pulmonary (other)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 116 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 116 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 116 at risk

Adverse event: Serum glutamic pyruvic transaminase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 116 at risk

Adverse event: Alkaline phosphase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 116 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 116 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 116 at risk

Adverse event: Magnesium, serum low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 116 at risk

Adverse event: Albumin, serum low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 116 at risk

Adverse event: Potassium, serum low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 116 at risk

Adverse event: Sensory alteration
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 116 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 116 at risk

Adverse event: Mood alteration, depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 116 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 116 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 116 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 116 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 116 at risk

Adverse event: Visual alteration
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 116 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 116 at risk

Adverse event: Hemorrhage, nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 116 at risk

Adverse event: Edema, limb
Serious: no
Organ System: General disorders
Frequency: 16 affected / 116 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 116 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 116 at risk