Study: NCT02520661

Adverse event: Blood and Lymphatic Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 992 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 992 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 992 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 992 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 992 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 992 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 992 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 992 at risk

Adverse event: Neoplasms benign, malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 992 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 992 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 992 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 992 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 992 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 992 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 992 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 992 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Notes: There is one 'unknown' event counted in this category.
Frequency: 7 affected / 992 at risk

Adverse event: Hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 992 at risk

Adverse event: Immune System Disorders
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 992 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 992 at risk

Adverse event: Injury, poisoning, and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 992 at risk

Adverse event: Metabolism and Nutrition Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 992 at risk

Adverse event: Musculoskeletal and connective tissues disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 992 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 992 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 992 at risk

Adverse event: Renal and Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 992 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 992 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 992 at risk

Adverse event: Surgical and Medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 992 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 992 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 987 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 987 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 987 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 987 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 987 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 987 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 987 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 987 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 987 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 987 at risk

Adverse event: Surgical and Medical Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 987 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 987 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 987 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 987 at risk

Adverse event: Endocrine Disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 987 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 987 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Notes: There is one 'unknown' event counted in this category.
Frequency: 5 affected / 987 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 987 at risk

Adverse event: Injury, poisoning, and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 987 at risk

Adverse event: Metabolism and Nutrition Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 987 at risk

Adverse event: Musculoskeletal and connective tissues disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 987 at risk

Adverse event: Neoplasms benign, malignant and unspecified
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 987 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 987 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 987 at risk

Adverse event: Renal and Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 987 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 987 at risk

Adverse event: Surgical and Medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 987 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 987 at risk