Study: NCT03720470

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Breast mass
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Dermatitis atopic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Night sweats
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Defect conduction intraventricular
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 131 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: External ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Vertigo positional
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 131 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 131 at risk

Adverse event: Tooth impacted
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Gallbladder polyp
Serious: no
Organ System: Hepatobiliary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Hepatic lesion
Serious: no
Organ System: Hepatobiliary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 131 at risk

Adverse event: Eczema herpeticum
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Eczema infected
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 131 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 131 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 131 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 9 affected / 131 at risk

Adverse event: Ophthalmic herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Skin bacterial infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Staphylococcal skin infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 6 affected / 131 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 131 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 131 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 131 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Traumatic haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 131 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 5 affected / 131 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Mandibular mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 131 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 131 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 6 affected / 131 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 131 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 131 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 131 at risk

Adverse event: Pulmonary mass
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Snoring
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Alopecia areata
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Angioedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 131 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Intertrigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 131 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 131 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Drug-induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Oral herpes
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Muscle injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Tendon injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Defect conduction intraventricular
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Conjunctival irritation
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 238 at risk

Adverse event: Swelling of eyelid
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Anal pruritus
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 238 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 10 affected / 238 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Medical device site rash
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Swelling face
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Xerosis
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 238 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 5 affected / 238 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 5 affected / 238 at risk

Adverse event: Eczema herpeticum
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 22 affected / 238 at risk

Adverse event: Ophthalmic herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 238 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Tinea versicolour
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 12 affected / 238 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 238 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Eye injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Medication error
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Scapula fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Soft tissue injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 7 affected / 238 at risk

Adverse event: Electrocardiogram T wave amplitude increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Natural killer cell count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Arthropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Synovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 238 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: External compression headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 10 affected / 238 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Nerve compression
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 238 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Hypomenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 238 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 7 affected / 238 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 7 affected / 238 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Dyshidrotic eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Keratosis pilaris
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 238 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Seborrhoea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 238 at risk

Adverse event: Victim of crime
Serious: no
Organ System: Social circumstances
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Rotator cuff repair
Serious: no
Organ System: Surgical and medical procedures
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Aortic stenosis
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Essential hypertension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 238 at risk

Adverse event: Eosinophil percentage increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 238 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 226 at risk

Adverse event: Lymphadenitis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Microcytic anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Dermoid cyst
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Eyelid pain
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Eyelids pruritus
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 226 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 226 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 226 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Faeces soft
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 226 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 25 affected / 226 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 226 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 226 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Mass
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Therapeutic response unexpected
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Liver disorder
Serious: no
Organ System: Hepatobiliary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Abscess limb
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 226 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Erysipelas
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 226 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 8 affected / 226 at risk

Adverse event: Herpes virus infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 226 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 15 affected / 226 at risk

Adverse event: Ophthalmic herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Perichondritis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Pharyngitis bacterial
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Pulpitis dental
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Pustule
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Sinusitis bacterial
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Skin bacterial infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 9 affected / 226 at risk

Adverse event: Ureaplasma infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 7 affected / 226 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 226 at risk

Adverse event: Wound haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 6 affected / 226 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 226 at risk

Adverse event: Lipids increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Natural killer cell count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 226 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: T-lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Anogenital warts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 7 affected / 226 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 15 affected / 226 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Parosmia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Apathy
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Depression suicidal
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Ovarian cyst
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Ovarian disorder
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 226 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Nasal crusting
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Nasal dryness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 15 affected / 226 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 226 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Nail bed disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Nail fold inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Neutrophilic dermatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 226 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Seborrhoea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 226 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 226 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Microcytic anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 242 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Asthenopia
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 242 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 242 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Noninfective conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Presbyopia
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 242 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 242 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 7 affected / 242 at risk

Adverse event: Noninfective gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 242 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 242 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 242 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Allergy to chemicals
Serious: no
Organ System: Immune system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 15 affected / 242 at risk

Adverse event: Dermatophytosis of nail
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Epstein-Barr virus infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 242 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 242 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Herpes dermatitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 242 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Malassezia infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 23 affected / 242 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 5 affected / 242 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 242 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 242 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 242 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 9 affected / 242 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 242 at risk

Adverse event: Urinary tract infection bacterial
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 242 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Clavicle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Eye injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Biopsy endometrium
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 242 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 242 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 7 affected / 242 at risk

Adverse event: Foot deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 13 affected / 242 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 242 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 242 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 242 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 242 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Neurodermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Pruritus allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 242 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 60 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 60 at risk

Adverse event: Gastrointestinal viral infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Nasal herpes
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 5 affected / 57 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 57 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 57 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 57 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 57 at risk

Adverse event: Tinea versicolour
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 57 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 57 at risk

Adverse event: Bronchitis bacterial
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 57 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 57 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 57 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 57 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 57 at risk

Adverse event: Enteritis infectious
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Defect conduction intraventricular
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 217 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 217 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Biliary colic
Serious: no
Organ System: Hepatobiliary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 217 at risk

Adverse event: Eczema herpeticum
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 217 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 217 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 217 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 6 affected / 217 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 217 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 217 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Asymptomatic bacteriuria
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Gastrointestinal viral infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Genital herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Urine analysis abnormal
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 217 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 217 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Calculus urinary
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Leukocyturia
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Balanoposthitis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 3 affected / 217 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 217 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 217 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 217 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Eczema eyelids
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 208 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 208 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 9 affected / 208 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 5 affected / 208 at risk

Adverse event: Bronchitis bacterial
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Bronchitis viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Epicondylitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 208 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 208 at risk

Adverse event: Natural killer cell count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 208 at risk

Adverse event: Urinary tract inflammation
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Nasal crusting
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 4 affected / 208 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 208 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 208 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 208 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 208 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Defect conduction intraventricular
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Congenital lacrimal passage anomaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Eyelid cyst
Serious: no
Organ System: Eye disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Gastritis erosive
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Allergy to chemicals
Serious: no
Organ System: Immune system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 223 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 5 affected / 223 at risk

Adverse event: Ophthalmic herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 7 affected / 223 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Bronchitis bacterial
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Humerus fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 223 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 2 affected / 223 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Frequency: 1 affected / 223 at risk