Study: NCT01184898

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Bone marrow cellularity
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: Left ventricular failure
Frequency: 1 affected / 36 at risk

Adverse event: Prolonged QTc interval
Serious: yes
Organ System: General disorders
Notes: Electrocardiogram QT prolonged
Frequency: 1 affected / 36 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Respiratory syncytial virus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 36 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 21 affected / 36 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 28 affected / 36 at risk

Adverse event: Pain from bone marrow biopsy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 36 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Generalized achiness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 36 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 36 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 30 affected / 36 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 36 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 13 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 36 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 36 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 36 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 36 at risk

Adverse event: Joint pain/stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 5 affected / 36 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 36 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Bleeding gums
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Cellultitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Lesions
Serious: no
Organ System: General disorders
Frequency: 5 affected / 36 at risk

Adverse event: Pain at PICC site
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Gingival pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 36 at risk

Adverse event: Dysphonia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 36 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 36 at risk

Adverse event: Fungal pneumonia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 36 at risk

Adverse event: Blotchy face with itchiness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hip pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 36 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 7 affected / 36 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Mental status change/confusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 36 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 36 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 36 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 36 at risk

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 36 at risk

Adverse event: Stool incontinence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 36 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Difficulty swallowing
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 36 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 8 affected / 36 at risk

Adverse event: Retching
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Heart irregularity
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Low urine output
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Generalized weakness
Serious: no
Organ System: General disorders
Frequency: 11 affected / 36 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Sepsis
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 36 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 36 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Burning sensation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 36 at risk

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Sweats
Serious: no
Organ System: General disorders
Frequency: 10 affected / 36 at risk

Adverse event: Eye pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Clostridium difficile colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Arm pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 36 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 36 at risk

Adverse event: Trouble sleeping
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Gas pains
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 36 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 36 at risk

Adverse event: Numbness/tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 36 at risk

Adverse event: Muscle ache/pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Post nasal drip
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dry oropharynx
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Folliculitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Fullness sensation in stomach
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Mouth soreness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Pain with ambulation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Oesophageal discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Breathing difficulty
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 36 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 8 affected / 36 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 36 at risk

Adverse event: Chest pain upon cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Floaters in both eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Anal fissure
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Elevated creatinine level
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Bilateral cracks in lung
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Fullness in abdomen upon cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Swollen throat/pharyngeal abscess
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Upper extremity swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Decreased musculature
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Swelling face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Glossodynia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 36 at risk

Adverse event: Coarse lung sounds
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Decreased breath sounds
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 36 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 21 affected / 36 at risk

Adverse event: Disseminated intravascular coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Generalized pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Dry mucous membrane
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 36 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 36 at risk

Adverse event: Lip pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 36 at risk

Adverse event: Decreased range of motion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Spinal change
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: B-12 deficiency
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 36 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pelvis pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Bladder spasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Distension
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Saddle anesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Redness at PICC site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 36 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 36 at risk

Adverse event: Candida infection
Serious: no
Organ System: General disorders
Frequency: 5 affected / 36 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pulmonary nodules
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ears popping
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ear pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Decreased pH
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Cracked tooth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 36 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Increased LFTs
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Obesity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Increased aspartate aminotransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 36 at risk

Adverse event: Reducible central hernia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Cold sore
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypoxia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Decreased electrolytes
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Eyelid dysfunction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Sinus pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 36 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Acute infusion reaction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Hemhorrage
Serious: no
Organ System: General disorders
Frequency: 5 affected / 36 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Increased alkaline phosphatase
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Increased alanine aminotransferase
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Slightly muddy sclera
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Decreased fibrinogen
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 36 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Xanthoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Rhinitis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Change in signature
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Elevated cardiac troponin
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 36 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Blister on tongue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Blood infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Restrictive cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: MSSA VRE (infection)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Cholesteatoma
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 36 at risk

Adverse event: Heart palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 36 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 36 at risk

Adverse event: Increased INR (international normalized ratio)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hyopalbuminemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 36 at risk

Adverse event: Increased PTT (partial thromboblastin time)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 36 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: General incontinence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hemorrhoid pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Flat affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 36 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Groin pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Non-occlusive clot
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Increased PT (prothrombin time)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Low creatinine
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Abdominal cramping
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypouricaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: High creatinine
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Restlessness in legs
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Muscular atrophy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Gram-negative bacteria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: JVT (Jahn ventilating tube) to ears
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 36 at risk