Study: NCT02224729

Adverse event: Joint Function Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Death- Anaphylactic Shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Gout
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Syncope episode
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Alkaline Phosphate increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 24 at risk

Adverse event: Abdominal cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 24 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 24 at risk

Adverse event: AST increase
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 24 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Change in taste
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Confusional state
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Conjuctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 24 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Decreased Visual Field
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 24 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 24 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 24 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 24 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Hypomagnesium
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Infection site reaction
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 24 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Leg Pain (spasm)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 24 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 24 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Pain at port site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pain shoulder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pain- side of face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Rash unspecified
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Soreness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 24 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 24 at risk

Adverse event: Swelling L- Breast
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 24 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 24 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 24 at risk

Adverse event: ANC increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk