Study: NCT02814526

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 148 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 148 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 148 at risk

Adverse event: Neoplasms benign, malignant and unspecified (cysts and polyps) 1 1
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 148 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 148 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 148 at risk

Adverse event: Surgical and medical procedures 4 4
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 148 at risk

Adverse event: Vascular disorders 1 0
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 148 at risk

Adverse event: Cardiac disorders 11 9
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 148 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 148 at risk

Adverse event: Endocrine disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 148 at risk

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

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

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 13 affected / 148 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 148 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 148 at risk

Adverse event: Injury, poisoning and procedural complications 76 59
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 76 affected / 148 at risk

Adverse event: Investigations 6 8
Serious: no
Organ System: Investigations
Frequency: 6 affected / 148 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 148 at risk

Adverse event: Musculoskeletal and connective tissue disorders 78 70
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 78 affected / 148 at risk

Adverse event: Neoplasms benign, malignant and unspecified (cysts and polyps) 6 6
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 148 at risk

Adverse event: Nervous system disorders 18 29
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 148 at risk

Adverse event: Psychiatric disorders 4 6
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 148 at risk

Adverse event: Renal and urinary disorders 4 6
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 148 at risk

Adverse event: Reproductive system and breast disorders 1 0
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 148 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders 8 3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 148 at risk

Adverse event: Skin and subcutaneous tissue disorders 8 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 148 at risk

Adverse event: Surgical and medical procedures 19 17
Serious: no
Organ System: Surgical and medical procedures
Frequency: 19 affected / 148 at risk

Adverse event: Vascular disorders 9 3
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 148 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 148 at risk

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

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 148 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 148 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 148 at risk

Adverse event: Neoplasms benign, malignant and unspecified (cysts and polyps) 1 1
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 148 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 148 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 148 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders 0 1
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 148 at risk

Adverse event: Surgical and medical procedures 4 4
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 148 at risk

Adverse event: Cardiac disorders 11 9
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 148 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 148 at risk

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

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 148 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 15 affected / 148 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 148 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 148 at risk

Adverse event: Injury, poisoning and procedural complications 76 59
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 59 affected / 148 at risk

Adverse event: Investigations 6 8
Serious: no
Organ System: Investigations
Frequency: 8 affected / 148 at risk

Adverse event: Musculoskeletal and connective tissue disorders 78 70
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 70 affected / 148 at risk

Adverse event: Neoplasms benign, malignant and unspecified (cysts and polyps) 6 6
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 148 at risk

Adverse event: Nervous system disorders 18 29
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 148 at risk

Adverse event: Psychiatric disorders 4 6
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 148 at risk

Adverse event: Renal and urinary disorders 4 6
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 148 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders 8 3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 148 at risk

Adverse event: Skin and subcutaneous tissue disorders 8 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 148 at risk

Adverse event: Surgical and medical procedures 19 17
Serious: no
Organ System: Surgical and medical procedures
Frequency: 17 affected / 148 at risk

Adverse event: Vascular disorders 9 3
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 148 at risk