Study: NCT02316470

Adverse event: Histoplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 148 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 148 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 148 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 148 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 148 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 148 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 148 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 148 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 33 affected / 148 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 25 affected / 148 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 17 affected / 148 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 13 affected / 148 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 9 affected / 148 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 148 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 148 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 148 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 148 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 148 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 148 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 148 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 148 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 152 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 152 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 152 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 62 affected / 152 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 32 affected / 152 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 30 affected / 152 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 23 affected / 152 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 18 affected / 152 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 14 affected / 152 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 14 affected / 152 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 152 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 152 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 152 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 152 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 152 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 152 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 152 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 152 at risk

Adverse event: Incarcerated incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 152 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 60 affected / 152 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 152 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 21 affected / 152 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 20 affected / 152 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 15 affected / 152 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 17 affected / 152 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 12 affected / 152 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 152 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 152 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 152 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 152 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 152 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 48 at risk

Adverse event: Inguinal hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 48 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 48 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 48 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 48 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 48 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 48 at risk