Study: NCT01559935

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: car phase
Frequency: 2 affected / 72 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Vascular disorders
Notes: car phase
Frequency: 2 affected / 72 at risk

Adverse event: abnominal infection
Serious: yes
Organ System: Infections and infestations
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: car phase
Frequency: 3 affected / 72 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: car phase
Frequency: 2 affected / 72 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: car phase
Frequency: 2 affected / 72 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: atrial fibrilation
Serious: yes
Organ System: Cardiac disorders
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: massive heart attack
Serious: yes
Organ System: Cardiac disorders
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: Surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: increased creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: car phase
Frequency: 1 affected / 72 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: BiRD phase
Frequency: 1 affected / 58 at risk

Adverse event: abdominal pain (small intestinal obstruction)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: BiRD phase
Frequency: 1 affected / 58 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Notes: BiRD phase
Frequency: 1 affected / 58 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Maintenance phase
Frequency: 1 affected / 54 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Maintenance phase
Frequency: 4 affected / 54 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Maintenance phase
Frequency: 1 affected / 54 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Notes: Maintenance phase
Frequency: 1 affected / 54 at risk

Adverse event: enterocolitis infection
Serious: yes
Organ System: Infections and infestations
Notes: Maintenance phase
Frequency: 1 affected / 54 at risk

Adverse event: cardiac chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Maintenance phase
Frequency: 1 affected / 54 at risk

Adverse event: Spinal cord compression
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 1 affected / 54 at risk

Adverse event: creatinine increase
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 1 affected / 54 at risk

Adverse event: secondary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Maintenance phase
Frequency: 1 affected / 54 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Car phase
Frequency: 52 affected / 72 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Car phase
Frequency: 64 affected / 72 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Car phase
Frequency: 13 affected / 72 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Car phase
Frequency: 25 affected / 72 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Car phase
Frequency: 69 affected / 72 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Car phase
Frequency: 13 affected / 72 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Car phase
Frequency: 18 affected / 72 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Car phase
Frequency: 17 affected / 72 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Car phase
Frequency: 6 affected / 72 at risk

Adverse event: diarhhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Car phase
Frequency: 25 affected / 72 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Car phase
Frequency: 8 affected / 72 at risk

Adverse event: flatulance
Serious: no
Organ System: Gastrointestinal disorders
Notes: Car phase
Frequency: 7 affected / 72 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 56 affected / 72 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 42 affected / 72 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 21 affected / 72 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 63 affected / 72 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 35 affected / 72 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 20 affected / 72 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 4 affected / 72 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 14 affected / 72 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 10 affected / 72 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 39 affected / 72 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 23 affected / 72 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 5 affected / 72 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 8 affected / 72 at risk

Adverse event: elevated ALT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 26 affected / 72 at risk

Adverse event: elevated AST
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 30 affected / 72 at risk

Adverse event: elevated alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 34 affected / 72 at risk

Adverse event: increased creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Car phase
Frequency: 35 affected / 72 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Car phase
Frequency: 27 affected / 72 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Car phase
Frequency: 22 affected / 72 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Car phase
Frequency: 4 affected / 72 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Car phase
Frequency: 12 affected / 72 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: Car phase
Frequency: 10 affected / 72 at risk

Adverse event: anxiety/stress
Serious: no
Organ System: Nervous system disorders
Notes: Car phase
Frequency: 13 affected / 72 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Car phase
Frequency: 6 affected / 72 at risk

Adverse event: dizziness / lightheaded
Serious: no
Organ System: Nervous system disorders
Notes: Car phase
Frequency: 9 affected / 72 at risk

Adverse event: paresthesias
Serious: no
Organ System: Nervous system disorders
Notes: Car phase
Frequency: 4 affected / 72 at risk

Adverse event: forgetful
Serious: no
Organ System: Nervous system disorders
Notes: Car phase
Frequency: 4 affected / 72 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Car phase
Frequency: 4 affected / 72 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Car phase
Frequency: 12 affected / 72 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Notes: Car phase
Frequency: 5 affected / 72 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Notes: Car phase
Frequency: 4 affected / 72 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Notes: Car phase
Frequency: 7 affected / 72 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Notes: Car phase
Frequency: 14 affected / 72 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Car phase
Frequency: 4 affected / 72 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Vascular disorders
Notes: Car phase
Frequency: 14 affected / 72 at risk

Adverse event: muscle spasms/cramps
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Car phase
Frequency: 13 affected / 72 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Car phase
Frequency: 6 affected / 72 at risk

Adverse event: pain in legs
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Car phase
Frequency: 8 affected / 72 at risk

Adverse event: hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Car phase
Frequency: 7 affected / 72 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Car phase
Frequency: 17 affected / 72 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Car phase
Frequency: 4 affected / 72 at risk

Adverse event: lower extremity pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Car phase
Frequency: 4 affected / 72 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Car phase
Frequency: 7 affected / 72 at risk

Adverse event: high BNP
Serious: no
Organ System: Cardiac disorders
Notes: Car phase
Frequency: 10 affected / 72 at risk

Adverse event: low eGFR
Serious: no
Organ System: Renal and urinary disorders
Notes: Car phase
Frequency: 37 affected / 72 at risk

Adverse event: genitourinary frequency
Serious: no
Organ System: Renal and urinary disorders
Notes: Car phase
Frequency: 4 affected / 72 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Car phase
Frequency: 11 affected / 72 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Car phase
Frequency: 12 affected / 72 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Car phase
Frequency: 10 affected / 72 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Car phase
Frequency: 4 affected / 72 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Car phase
Frequency: 12 affected / 72 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Car phase
Frequency: 5 affected / 72 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Car phase
Frequency: 4 affected / 72 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: BiRD phase
Frequency: 6 affected / 58 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: BiRD phase
Frequency: 5 affected / 58 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: BiRD phase
Frequency: 5 affected / 58 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: BiRD phase
Frequency: 4 affected / 58 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: BiRD phase
Frequency: 15 affected / 58 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: BiRD phase
Frequency: 7 affected / 58 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: BiRD phase
Frequency: 4 affected / 58 at risk

Adverse event: diarhhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: BiRD phase
Frequency: 4 affected / 58 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: BiRD phase
Frequency: 4 affected / 58 at risk

Adverse event: flatulance
Serious: no
Organ System: Gastrointestinal disorders
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: BiRD phase
Frequency: 6 affected / 58 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: BiRD phase
Frequency: 14 affected / 58 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: BiRD phase
Frequency: 4 affected / 58 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: BiRD phase
Frequency: 7 affected / 58 at risk

Adverse event: elevated ALT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: ALK increase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: BiRD phase
Frequency: 6 affected / 58 at risk

Adverse event: increased creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: BiRD phase
Frequency: 4 affected / 58 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: BiRD phase
Frequency: 5 affected / 58 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: BiRD phase
Frequency: 9 affected / 58 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: BiRD phase
Frequency: 11 affected / 58 at risk

Adverse event: dizziness / lightheaded
Serious: no
Organ System: Nervous system disorders
Notes: BiRD phase
Frequency: 5 affected / 58 at risk

Adverse event: parethesias
Serious: no
Organ System: Nervous system disorders
Notes: BiRD phase
Frequency: 4 affected / 58 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: BiRD phase
Frequency: 17 affected / 58 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Notes: BiRD phase
Frequency: 7 affected / 58 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Notes: BiRD phase
Frequency: 10 affected / 58 at risk

Adverse event: cushingoid appearance
Serious: no
Organ System: Vascular disorders
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: muscle spasms/cramps
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: BiRD phase
Frequency: 6 affected / 58 at risk

Adverse event: hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: BiRD phase
Frequency: 13 affected / 58 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: low eGFR
Serious: no
Organ System: Renal and urinary disorders
Notes: BiRD phase
Frequency: 4 affected / 58 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: BiRD phase
Frequency: 3 affected / 58 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Maintenance phase
Frequency: 18 affected / 54 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Maintenance phase
Frequency: 11 affected / 54 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maintenance phase
Frequency: 13 affected / 54 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maintenance phase
Frequency: 4 affected / 54 at risk

Adverse event: diarhhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maintenance phase
Frequency: 20 affected / 54 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maintenance phase
Frequency: 7 affected / 54 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: flatulance
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 7 affected / 54 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 7 affected / 54 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 4 affected / 54 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 13 affected / 54 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 8 affected / 54 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: elevated ALT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: elevated AST
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 4 affected / 54 at risk

Adverse event: increased creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance phase
Frequency: 7 affected / 54 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Notes: Maintenance phase
Frequency: 4 affected / 54 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Notes: Maintenance phase
Frequency: 4 affected / 54 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Maintenance phase
Frequency: 7 affected / 54 at risk

Adverse event: anxiety/stress
Serious: no
Organ System: Psychiatric disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: dizziness / lightheaded
Serious: no
Organ System: Nervous system disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Notes: Maintenance phase
Frequency: 14 affected / 54 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: muscle spasms/cramps
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 6 affected / 54 at risk

Adverse event: chest pain (muscular)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 4 affected / 54 at risk

Adverse event: pain in legs
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 10 affected / 54 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 8 affected / 54 at risk

Adverse event: arthralgias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 11 affected / 54 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: lower extremity pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 6 affected / 54 at risk

Adverse event: upper extremity pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 6 affected / 54 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Maintenance phase
Frequency: 10 affected / 54 at risk

Adverse event: skin darknening
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Maintenance phase
Frequency: 4 affected / 54 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Maintenance phase
Frequency: 7 affected / 54 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Maintenance phase
Frequency: 5 affected / 54 at risk

Adverse event: genitourinary frequency
Serious: no
Organ System: Renal and urinary disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Maintenance phase
Frequency: 13 affected / 54 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Maintenance phase
Frequency: 9 affected / 54 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Maintenance phase
Frequency: 7 affected / 54 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Maintenance phase
Frequency: 22 affected / 54 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Maintenance phase
Frequency: 4 affected / 54 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: Maintenance phase
Frequency: 3 affected / 54 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Maintenance phase
Frequency: 4 affected / 54 at risk