Study: NCT01244906

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: GI bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 26 at risk

Adverse event: VOD
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Severe Hyperglycemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 26 at risk

Adverse event: "cold sweats"
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: "cold" feeling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 26 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 26 at risk

Adverse event: abdominal discomfort/pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 26 at risk

Adverse event: abdominal distention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 26 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 26 at risk

Adverse event: increased alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 26 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: increased alanine aminotransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 18 affected / 26 at risk

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

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

Adverse event: anorexia/decreased oral intake
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 26 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 26 at risk

Adverse event: arm pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: increased aspartate aminotransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 26 at risk

Adverse event: Ataxia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 26 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 26 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 26 at risk

Adverse event: bilateral knee pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: BKV cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 26 at risk

Adverse event: bladder cramping
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 26 at risk

Adverse event: Bladder pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 26 at risk

Adverse event: bladder spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 26 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 26 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 26 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 26 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 26 at risk

Adverse event: Clostridium difficile colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 26 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: chills/rigors
Serious: no
Organ System: General disorders
Frequency: 14 affected / 26 at risk

Adverse event: CMV reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 26 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 26 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 26 at risk

Adverse event: Breath sounds abnormal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: increased creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 26 at risk

Adverse event: central venous catheter pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 26 at risk

Adverse event: central venous catheter site drainage
Serious: no
Organ System: General disorders
Frequency: 5 affected / 26 at risk

Adverse event: central venous catheter site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 26 at risk

Adverse event: deconditioning
Serious: no
Organ System: General disorders
Frequency: 10 affected / 26 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 26 at risk

Adverse event: decreased bowel movement frequency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: decreased breath sounds
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 26 at risk

Adverse event: decreased fluid intake
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 26 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 26 at risk

Adverse event: diaphoretic skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 26 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 26 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 26 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 26 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 26 at risk

Adverse event: Lip dry
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 26 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 26 at risk

Adverse event: deep venous thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 26 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 26 at risk

Adverse event: ear fullness/pressure
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 26 at risk

Adverse event: electrolyte wasting syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: enlarged lymph nodes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 26 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: facial edema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 22 affected / 26 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 26 at risk

Adverse event: Flat affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 26 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 26 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 26 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 26 at risk

Adverse event: gas/flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: generalized achiness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 26 at risk

Adverse event: generalized skin erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 26 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 26 at risk

Adverse event: skin GVHD
Serious: no
Organ System: Immune system disorders
Frequency: 11 affected / 26 at risk

Adverse event: gut GVHD
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 26 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 26 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 26 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: perirectal bleeding/hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 26 at risk

Adverse event: hemorrhodial edema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: hemorrhodial pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 26 at risk

Adverse event: Hernia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Gastrointestinal sounds abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 26 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 26 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 26 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 26 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 26 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 26 at risk

Adverse event: hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 26 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 26 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 26 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 26 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 26 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 26 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 26 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 26 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: stool incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: increased respiration rate
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 26 at risk

Adverse event: joint aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: lower-extremity edema
Serious: no
Organ System: General disorders
Frequency: 17 affected / 26 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 26 at risk

Adverse event: limited mobility
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 26 at risk

Adverse event: Lip oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: loss of coordination/balance
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 26 at risk

Adverse event: lung crackles
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 26 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: mouth sores
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 26 at risk

Adverse event: mouth tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 26 at risk

Adverse event: MRSE bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 26 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 26 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 26 at risk

Adverse event: nasal drainage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 26 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 26 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 26 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 26 at risk

Adverse event: oral erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 26 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: pain during defication
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: pain with breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: lower-extremity pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 26 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 26 at risk

Adverse event: Pallor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: parainfluenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: penile lesions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: perihepatic ascites
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 26 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 26 at risk

Adverse event: periorbital redness
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 26 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: perirectal irritation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: perirectal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Petechiae
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 26 at risk

Adverse event: pleuritic chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 26 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: post-nasal drip
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 26 at risk

Adverse event: pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: pulmonary nodules
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: pulmonary opacites
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 26 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 26 at risk

Adverse event: rhinovirus/URI
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 26 at risk

Adverse event: Rhonchi
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: ribcage tenderness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: seasonal allergies
Serious: no
Organ System: General disorders
Frequency: 9 affected / 26 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 26 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 26 at risk

Adverse event: sinus drainage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 26 at risk

Adverse event: Paranasal sinus discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Chronic sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: skin color changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: skin lesions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 26 at risk

Adverse event: skin sensitivity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 26 at risk

Adverse event: Splenomegaly
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: staphylococcus epidermis bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: steroid-induced diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 26 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: suprapubic tenderness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: sweats
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 26 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 26 at risk

Adverse event: taste changes
Serious: no
Organ System: General disorders
Frequency: 7 affected / 26 at risk

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

Adverse event: tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 26 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 26 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 26 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 26 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 26 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 26 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 26 at risk

Adverse event: visual changes
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 26 at risk

Adverse event: veno-occlusive disease
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hypovolaemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 26 at risk

Adverse event: VRE positive
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 26 at risk

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

Adverse event: generalized weakness
Serious: no
Organ System: General disorders
Frequency: 15 affected / 26 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 26 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 26 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 26 at risk