Study: NCT02960490

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Eustachian tube patulous
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 33 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 33 at risk

Adverse event: Joint destruction
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 33 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 31 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Faeces soft
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Breast abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 31 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Cell marker increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 31 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 15 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 14 at risk

Adverse event: Eustachian tube patulous
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 14 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 14 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Joint destruction
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 14 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 14 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 14 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Breast abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 14 at risk

Adverse event: Cell marker increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Tenosynovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 14 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Gastroenteritis norovirus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 12 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 13 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 13 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 13 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Diverticulum intestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 13 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Bacterial diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Oesophageal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Intervertebral disc compression
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Poor peripheral circulation
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk

Adverse event: Oesophageal achalasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Joint destruction
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Eustachian tube patulous
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vertigo positional
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Epigastric discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 11 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Dermatophytosis of nail
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 13 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 13 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Breast abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 13 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 13 at risk

Adverse event: Cell marker increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Tenosynovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 13 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 13 at risk

Adverse event: Cushingoid
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 13 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 13 at risk

Adverse event: Atypical mycobacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 13 at risk

Adverse event: Dislocation of vertebra
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Tendon rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Hypovitaminosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Chloasma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 10 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vertigo positional
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pulpless tooth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hepatic steatosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 10 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Uterine leiomyoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk