Study: NCT02296775

Adverse event: Penumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 91 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 4 affected / 91 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 2 affected / 91 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 2 affected / 91 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Bacteriuria
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Pyelonephritis chronic
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Vulvovaginitis
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 2 affected / 91 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 2 affected / 91 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 3 affected / 91 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Spondylitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 2 affected / 91 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Sudden death
Serious: no
Organ System: General disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 91 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 3 affected / 91 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 91 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Dyshidrotic eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Trachycardia
Serious: no
Organ System: Cardiac disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 91 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 92 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 92 at risk

Adverse event: Febile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 92 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Spinal cord compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 92 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 3 affected / 92 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 4 affected / 92 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 2 affected / 92 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 2 affected / 92 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 2 affected / 92 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 2 affected / 92 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Wrist deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 4 affected / 92 at risk

Adverse event: Generalized oedema
Serious: no
Organ System: General disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 3 affected / 92 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 2 affected / 92 at risk

Adverse event: Choking sensation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Allergic bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 92 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 5 affected / 92 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 2 affected / 92 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 92 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 92 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AEs are listed as TEAEs for this study.
Frequency: 1 affected / 92 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 2 affected / 92 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 92 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 92 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All AEs are listed as TEAEs for this study
Frequency: 2 affected / 92 at risk

Adverse event: Humerus fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 92 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 92 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 92 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 92 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 92 at risk

Adverse event: H1N1 influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 93 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 93 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 93 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 93 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 93 at risk

Adverse event: Intestitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 5 affected / 93 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 2 affected / 93 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: H1N1 influenza
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Acid peptic disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Hyperchlorhydia
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Blood creatnine increased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 2 affected / 93 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 2 affected / 93 at risk

Adverse event: Myofascial pain syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 3 affected / 93 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 3 affected / 93 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Choking sensation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE's are listed as TEAE's for this study
Frequency: 1 affected / 93 at risk

Adverse event: Interstitial lung disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AEs are listed as TEAEs for this study.
Frequency: 1 affected / 93 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 2 affected / 93 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 2 affected / 93 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Femoral neck fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Forearm fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 2 affected / 93 at risk

Adverse event: Cervicobrachial syndrome
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Cardio-respiratory arrest
Serious: no
Organ System: Cardiac disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 2 affected / 93 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Vascular disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AEs are listed as TEAEs for this study
Frequency: 1 affected / 93 at risk