Study: NCT01936363

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Streptococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 32 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 32 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dermatitis acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Subileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 32 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 32 at risk

Adverse event: Anaemia of chronic disease
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 32 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 32 at risk

Adverse event: Macular detachment
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 32 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 32 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 32 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Subretinal fluid
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 32 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 32 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 32 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 32 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 32 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 32 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 32 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 11 affected / 32 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 32 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 9 affected / 32 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 32 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 32 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 32 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 32 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 32 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 32 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 32 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 32 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 32 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 32 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 32 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 32 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 32 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 32 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 32 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 32 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 32 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 32 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 32 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 32 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 32 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 32 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 32 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Mass
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 32 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 32 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 32 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hypertrichosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 32 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Peritonitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 32 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 32 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 32 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 32 at risk

Adverse event: Macular detachment
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 32 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 32 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 32 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 32 at risk

Adverse event: Subretinal fluid
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 32 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 32 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 32 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 32 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 15 affected / 32 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 32 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 32 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 32 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 32 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 32 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 32 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 32 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 32 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 32 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 32 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 32 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 32 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 32 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 32 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 32 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 32 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 32 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 32 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 32 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 32 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 32 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 32 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 32 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk