Study: NCT02199691

Adverse event: Faecaloma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 503 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 503 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 503 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 503 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 25 affected / 503 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 224 affected / 503 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 27 affected / 503 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 130 affected / 503 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 503 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 503 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 175 affected / 503 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 155 affected / 503 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 501 at risk

Adverse event: Abnormal behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 501 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 501 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 501 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 37 affected / 501 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 209 affected / 501 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 32 affected / 501 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 131 affected / 501 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 501 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 501 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 173 affected / 501 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 159 affected / 501 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 392 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 392 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 392 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 392 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 44 affected / 392 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 327 affected / 392 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 42 affected / 392 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 113 affected / 392 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 392 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 392 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 239 affected / 392 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 137 affected / 392 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 296 at risk

Adverse event: Staphylococcal scalded skin syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 296 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 296 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 24 affected / 296 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 234 affected / 296 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 32 affected / 296 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 81 affected / 296 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 296 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 296 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 161 affected / 296 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 87 affected / 296 at risk