Study: NCT02792218

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 465 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 465 at risk

Adverse event: Deafness neurosensory
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 465 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 465 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 465 at risk

Adverse event: Intestinal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 465 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 465 at risk

Adverse event: Obstructive pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 465 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 465 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 465 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 465 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 465 at risk

Adverse event: Cholelithiasis migration
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 465 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 465 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 465 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 465 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 465 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 465 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 465 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 465 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 465 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 465 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 465 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 465 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 465 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 465 at risk

Adverse event: Injection related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 465 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 465 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 465 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 465 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 465 at risk

Adverse event: Traumatic pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 465 at risk

Adverse event: Ulna fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 465 at risk

Adverse event: Liver function test increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 465 at risk

Adverse event: Psychiatric evaluation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 465 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 465 at risk

Adverse event: Femoroacetabular impingement
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 465 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 465 at risk

Adverse event: Invasive breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 465 at risk

Adverse event: Malignant melanoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 465 at risk

Adverse event: Non-Hodgkin's lymphoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 465 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 465 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 465 at risk

Adverse event: Lumbosacral radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 465 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 465 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 465 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 465 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 465 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 465 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 465 at risk

Adverse event: Somatic symptom disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 465 at risk

Adverse event: Stress
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 465 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 465 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 465 at risk

Adverse event: Adnexa uteri cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 465 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 465 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 465 at risk

Adverse event: Pulmonary sarcoidosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 465 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 465 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 465 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 465 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 46 affected / 465 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 41 affected / 465 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 465 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 82 affected / 465 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 465 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 465 at risk

Adverse event: Injection related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 74 affected / 465 at risk

Adverse event: Blood immunoglobulin M decreased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 465 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 465 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 465 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 465 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 59 affected / 465 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 465 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 465 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 465 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 465 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 462 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 462 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 462 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 462 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 462 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 462 at risk

Adverse event: Abscess sweat gland
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Campylobacter infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Pneumonia influenzal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Salpingo-oophoritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Tick-borne viral encephalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 462 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 462 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 462 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 462 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 462 at risk

Adverse event: Jaw cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 462 at risk

Adverse event: Joint range of motion decreased
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 462 at risk

Adverse event: Morphoea
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 462 at risk

Adverse event: Synovial cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 462 at risk

Adverse event: Synovitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 462 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 462 at risk

Adverse event: Fibrosarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 462 at risk

Adverse event: Cerebellar ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 462 at risk

Adverse event: Cervicobrachial syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 462 at risk

Adverse event: Hemiplegic migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 462 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 462 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 462 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 462 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 462 at risk

Adverse event: Trigeminal neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 462 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 462 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 462 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 462 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 462 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 462 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 462 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 462 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 462 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 462 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 462 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 462 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 39 affected / 462 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 26 affected / 462 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 462 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 69 affected / 462 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 73 affected / 462 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 462 at risk

Adverse event: Injection related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 77 affected / 462 at risk

Adverse event: Blood immunoglobulin M decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 462 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 462 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 462 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 462 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 53 affected / 462 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 462 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 26 affected / 462 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 65 affected / 462 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 462 at risk