Study: NCT01992107

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1149 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1149 at risk

Adverse event: Hippocampal sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1149 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1149 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1149 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1149 at risk

Adverse event: Oppositional defiant disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1149 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 1149 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 95 affected / 1149 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 1149 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 73 affected / 1149 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 165 affected / 1149 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 244 affected / 1149 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 84 affected / 1149 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 188 affected / 1149 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 664 affected / 1149 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 59 affected / 1149 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 92 affected / 1149 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 63 affected / 1149 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 150 affected / 1149 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 204 affected / 1149 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 45 affected / 1149 at risk

Adverse event: Abscess of eyelid
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 579 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 579 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 579 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 579 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 579 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 579 at risk

Adverse event: Intentional self-injury
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 579 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 579 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 579 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 579 at risk

Adverse event: Henoch-Schonlein purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 579 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 579 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 579 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 579 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 29 affected / 579 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 82 affected / 579 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 121 affected / 579 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 48 affected / 579 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 105 affected / 579 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 324 affected / 579 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 579 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 43 affected / 579 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 579 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 84 affected / 579 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 105 affected / 579 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 579 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 570 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 570 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 570 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 570 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 570 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 21 affected / 570 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 82 affected / 570 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 110 affected / 570 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 42 affected / 570 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 78 affected / 570 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 315 affected / 570 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 570 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 45 affected / 570 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 570 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 66 affected / 570 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 88 affected / 570 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 570 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 2298 at risk

Adverse event: Abscess of eyelid
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2298 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2298 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2298 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2298 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2298 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2298 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2298 at risk

Adverse event: Hippocampal sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2298 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2298 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2298 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2298 at risk

Adverse event: Intentional self-injury
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2298 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2298 at risk

Adverse event: Oppositional defiant disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2298 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2298 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2298 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2298 at risk

Adverse event: Henoch-Schonlein purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2298 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 127 affected / 2298 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 177 affected / 2298 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 113 affected / 2298 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 123 affected / 2298 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 329 affected / 2298 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 475 affected / 2298 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 174 affected / 2298 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 371 affected / 2298 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1303 affected / 2298 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 115 affected / 2298 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 180 affected / 2298 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 131 affected / 2298 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 300 affected / 2298 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 397 affected / 2298 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 103 affected / 2298 at risk