Study: NCT02503202

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 265 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 265 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 265 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 265 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 265 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 265 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 265 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 265 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 265 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 265 at risk

Adverse event: Scapula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 265 at risk

Adverse event: Exostosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 265 at risk

Adverse event: Oropharyngeal squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 265 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 265 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 265 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 265 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 265 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 265 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 265 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 265 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 265 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 265 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 265 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 14 affected / 265 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 265 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 14 affected / 265 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 39 affected / 265 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 179 affected / 265 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 47 affected / 265 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 34 affected / 265 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 58 affected / 265 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 47 affected / 265 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 265 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 61 affected / 265 at risk

Adverse event: Autoimmune thyroiditis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 263 at risk

Adverse event: Incarcerated umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 263 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 263 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 263 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 263 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 263 at risk

Adverse event: Hyperglycaemic hyperosmolar nonketotic syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 263 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 263 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 263 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 263 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 263 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 263 at risk

Adverse event: Menometrorrhagia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 263 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 263 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 263 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 16 affected / 263 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 263 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 12 affected / 263 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 30 affected / 263 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 192 affected / 263 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 36 affected / 263 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 23 affected / 263 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 47 affected / 263 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 263 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 263 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 263 at risk

Adverse event: Conductive deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 263 at risk

Adverse event: Autoimmune thyroiditis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 263 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 263 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 263 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 263 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 263 at risk

Adverse event: Arthropod bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 263 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 263 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 263 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 263 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 263 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 263 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 263 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 20 affected / 263 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 263 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 18 affected / 263 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 39 affected / 263 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 185 affected / 263 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 49 affected / 263 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 29 affected / 263 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 63 affected / 263 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 263 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 263 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 263 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 260 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 260 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 260 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 260 at risk

Adverse event: Radicular pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 260 at risk

Adverse event: Ruptured ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 260 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 260 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 260 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 260 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 27 affected / 260 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 20 affected / 260 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 260 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 19 affected / 260 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 176 affected / 260 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 42 affected / 260 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 32 affected / 260 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 76 affected / 260 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 260 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 260 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 67 affected / 260 at risk

Adverse event: Abdominal incarcerated hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Arthropod bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 133 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 133 at risk

Adverse event: Breast cancer stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 133 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 133 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 133 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 133 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 133 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 4 affected / 133 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 133 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 133 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 133 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 133 at risk