Study: NCT03571607

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 4 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 18 affected / 48 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 10 affected / 47 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 41 affected / 52 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 16 affected / 47 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 7 affected / 48 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 53 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 3 affected / 48 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 15 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 12 affected / 49 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 153 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 26 affected / 141 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 2 affected / 136 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 47 affected / 142 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 10 affected / 135 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 96 affected / 145 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 153 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 17 affected / 136 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 8 affected / 134 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 153 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 153 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 153 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 153 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 19 affected / 138 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 153 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 38 affected / 139 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 153 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 33 affected / 141 at risk

Adverse event: Middle insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 153 at risk

Adverse event: Hyperventilation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 153 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 206 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 30 affected / 189 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 2 affected / 183 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 65 affected / 190 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 20 affected / 182 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 206 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 137 affected / 197 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 206 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 33 affected / 183 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 15 affected / 182 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 206 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 206 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 206 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 206 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 22 affected / 186 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 53 affected / 188 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Number of participants at risk = number of participants evaluable for the adverse event.
Frequency: 45 affected / 190 at risk

Adverse event: Middle insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 206 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Hyperventilation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk