Study: NCT01998841

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 84 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 84 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 84 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 15 affected / 84 at risk

Adverse event: Endocrine disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 84 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 84 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 39 affected / 84 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 84 affected / 84 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 60 affected / 84 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 17 affected / 84 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 84 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 64 affected / 84 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 66 affected / 84 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 43 affected / 84 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 18 affected / 84 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 24 affected / 84 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 84 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 84 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 84 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 20 affected / 84 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 84 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 21 affected / 84 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 84 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 84 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 10 affected / 84 at risk

Adverse event: Endocrine disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 84 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 84 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 39 affected / 84 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 81 affected / 84 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 58 affected / 84 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 15 affected / 84 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 84 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 65 affected / 84 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 70 affected / 84 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 44 affected / 84 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 84 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 35 affected / 84 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 84 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 41 affected / 84 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 84 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 84 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 84 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 83 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 83 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 83 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 20 affected / 83 at risk

Adverse event: Endocrine disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 83 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 83 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 43 affected / 83 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 83 affected / 83 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 54 affected / 83 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 17 affected / 83 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 83 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 66 affected / 83 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 83 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 44 affected / 83 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 83 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 39 affected / 83 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 83 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 48 affected / 83 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 83 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 83 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 12 affected / 83 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 251 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 251 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 251 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 251 at risk

Adverse event: Pregnancy, puerperium and perinatal conditions
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 251 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 251 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 251 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 251 at risk

Adverse event: Social circumstances
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 251 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 251 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 251 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 251 at risk

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Congenital, familial and genetic disorders
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 251 at risk

Adverse event: Endocrine disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 251 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 251 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 251 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 251 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 45 affected / 251 at risk

Adverse event: Endocrine disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 18 affected / 251 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 166 affected / 251 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 121 affected / 251 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 248 affected / 251 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 174 affected / 251 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 49 affected / 251 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 89 affected / 251 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 195 affected / 251 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 198 affected / 251 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 131 affected / 251 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 45 affected / 251 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 98 affected / 251 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 251 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 127 affected / 251 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 53 affected / 251 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 44 affected / 251 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 28 affected / 251 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 147 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 147 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 147 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 147 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 147 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 147 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 147 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 147 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 20 affected / 147 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 147 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 72 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 72 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 72 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 72 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 72 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 72 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 72 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 72 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 72 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 72 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 219 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 219 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 219 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 219 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 219 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 219 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 219 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 219 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 219 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 219 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 219 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 219 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 219 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 75 affected / 219 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 33 affected / 129 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 219 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 219 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 219 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 219 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 30 affected / 219 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 219 at risk