Study: NCT01158118

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 23 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 23 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 23 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 23 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 23 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 23 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 23 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 23 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 23 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 23 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 23 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 23 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 23 at risk

Adverse event: Left chest fasciculations
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 23 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 23 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Oral dysaesthesia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Pain at catheter placement site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 23 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 23 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 23 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 23 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Salivary duct inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 23 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Transamintis
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 21 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 21 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 21 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 21 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 21 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 21 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 21 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 21 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 21 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 21 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 21 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Catheter site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 21 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 21 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 21 at risk

Adverse event: Dislocation Left Hip Hemiarthroplasty
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 9 affected / 21 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Oesophageal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Excessive dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 21 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 21 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 21 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

Adverse event: GVHD - Skin (Rash)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: HSV stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 21 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Haemolytic anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hepatic failure
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hip fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 21 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 21 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 21 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 21 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 21 at risk

Adverse event: Hypohidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 21 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 21 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 21 at risk

Adverse event: Jaundice
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Laryngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Lymphocyte count increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 21 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 21 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 21 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Oral HSV
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 21 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Blood phosphorus increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 21 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pleuritic pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 21 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Rash - GVHD (Chest)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Rash - GVHD (Palms)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Rash - GVHD (Skin in general)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 21 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 21 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 21 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 21 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 21 at risk

Adverse event: Spinal fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Stool VRE
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Tonsilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 21 at risk

Adverse event: Visual disturbance (purple lights)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 21 at risk