Study: NCT01664078

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 188 at risk

Adverse event: Congenital disorders
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 188 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 188 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 188 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 188 at risk

Adverse event: Injury, poisoning and procedural complications2
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 188 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 188 at risk

Adverse event: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 188 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 188 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 188 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 188 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 188 at risk

Adverse event: Blood and Lymphatic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 188 at risk

Adverse event: Metabolisms and Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 188 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 188 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 188 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 15 affected / 188 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 188 at risk

Adverse event: Injury, poisoning and procedural complications1
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 188 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 188 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 188 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 188 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 188 at risk

Adverse event: Vascular disorders4
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 188 at risk