Study: NCT01995487

Adverse event: blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 945 at risk

Adverse event: cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 159 affected / 945 at risk

Adverse event: ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 945 at risk

Adverse event: eye disorderd
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 945 at risk

Adverse event: gastrointestineal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 945 at risk

Adverse event: general disorders and administration site condition
Serious: yes
Organ System: General disorders
Frequency: 57 affected / 945 at risk

Adverse event: hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 945 at risk

Adverse event: immune system disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 945 at risk

Adverse event: infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 945 at risk

Adverse event: injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 945 at risk

Adverse event: metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 945 at risk

Adverse event: musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 945 at risk

Adverse event: neoplasms benign, malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 945 at risk

Adverse event: nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 26 affected / 945 at risk

Adverse event: psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 945 at risk

Adverse event: renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 945 at risk

Adverse event: reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 945 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 945 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 945 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 945 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 945 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 159 affected / 945 at risk

Adverse event: ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 945 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 945 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 945 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 57 affected / 945 at risk

Adverse event: hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 945 at risk

Adverse event: immune system disorders
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 945 at risk

Adverse event: infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 945 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 945 at risk

Adverse event: metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 945 at risk

Adverse event: musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 945 at risk

Adverse event: neoplasms benign, malignant and unspecified
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 945 at risk

Adverse event: nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 945 at risk

Adverse event: psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 34 affected / 945 at risk

Adverse event: renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 945 at risk

Adverse event: reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 945 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 945 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 945 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 945 at risk

Adverse event: blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 954 at risk

Adverse event: cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 124 affected / 954 at risk

Adverse event: ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 954 at risk

Adverse event: gastrointestineal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 954 at risk

Adverse event: general disorders and administration site condition
Serious: yes
Organ System: General disorders
Frequency: 71 affected / 954 at risk

Adverse event: hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 954 at risk

Adverse event: immune system disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 954 at risk

Adverse event: infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 954 at risk

Adverse event: injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 954 at risk

Adverse event: metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 954 at risk

Adverse event: musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 954 at risk

Adverse event: neoplasms benign, malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 19 affected / 954 at risk

Adverse event: nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 27 affected / 954 at risk

Adverse event: renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 954 at risk

Adverse event: reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 954 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 954 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 954 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 954 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 954 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 954 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 124 affected / 954 at risk

Adverse event: ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 954 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 954 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 71 affected / 954 at risk

Adverse event: hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 954 at risk

Adverse event: immune system disorders
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 954 at risk

Adverse event: infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 954 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 954 at risk

Adverse event: metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 954 at risk

Adverse event: musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 954 at risk

Adverse event: neoplasms benign, malignant and unspecified
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 19 affected / 954 at risk

Adverse event: nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 954 at risk

Adverse event: renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 954 at risk

Adverse event: reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 16 affected / 954 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 954 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 954 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 954 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 954 at risk