Study: NCT03058692

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 61 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 61 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 61 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited as 'feverishness'
Frequency: 2 affected / 61 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 22 affected / 61 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 61 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 5 affected / 61 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 33 affected / 61 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 9 affected / 61 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 61 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 61 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 61 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 61 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 61 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 59 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 59 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited as 'feverishness'
Frequency: 4 affected / 59 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 14 affected / 59 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 5 affected / 59 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 5 affected / 59 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 59 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 7 affected / 59 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 59 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 59 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 59 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 59 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 59 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 59 at risk