Study: NCT00345176

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 96 affected / 1012 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 1012 at risk

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 1012 at risk

Adverse event: Ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 1012 at risk

Adverse event: Congenital, familian and genetic disorders
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 1012 at risk

Adverse event: Endocrine disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 1012 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 1012 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 54 affected / 1012 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 1012 at risk

Adverse event: Immune system disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 1012 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 90 affected / 1012 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 76 affected / 1012 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 14 affected / 1012 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 1012 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 66 affected / 1012 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: 80 affected / 1012 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 66 affected / 1012 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1012 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 19 affected / 1012 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 1012 at risk

Adverse event: Respioratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 44 affected / 1012 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1012 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 32 affected / 1012 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 41 affected / 1012 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 55 affected / 1012 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 67 affected / 1012 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 88 affected / 1012 at risk

Adverse event: Vitreous disorder
Serious: no
Organ System: Eye disorders
Frequency: 133 affected / 1012 at risk

Adverse event: Change in bowel habit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 1012 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 1012 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 139 affected / 1012 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 1012 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 59 affected / 1012 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 110 affected / 1044 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 1044 at risk

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 1044 at risk

Adverse event: Ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 1044 at risk

Adverse event: Congenital, familian and genetic disorders
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1044 at risk

Adverse event: Endocrine disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 1044 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: Eye disorders
Frequency: 11 affected / 1044 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 50 affected / 1044 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 16 affected / 1044 at risk

Adverse event: Immune system disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1044 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 102 affected / 1044 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 62 affected / 1044 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 19 affected / 1044 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 1044 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 74 affected / 1044 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: 88 affected / 1044 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 74 affected / 1044 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 1044 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 25 affected / 1044 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 1044 at risk

Adverse event: Respioratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 1044 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 1044 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 29 affected / 1044 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 40 affected / 1044 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 39 affected / 1044 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 67 affected / 1044 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 110 affected / 1044 at risk

Adverse event: Vitreous disorder
Serious: no
Organ System: Eye disorders
Frequency: 154 affected / 1044 at risk

Adverse event: Change in bowel habit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 67 affected / 1044 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 69 affected / 1044 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 150 affected / 1044 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 75 affected / 1044 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 60 affected / 1044 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 119 affected / 1068 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 1068 at risk

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 1068 at risk

Adverse event: Ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 1068 at risk

Adverse event: Endocrine disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 1068 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 1068 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 51 affected / 1068 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 16 affected / 1068 at risk

Adverse event: Immune system disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 1068 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 103 affected / 1068 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 74 affected / 1068 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 1068 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 1068 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 71 affected / 1068 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: 83 affected / 1068 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 72 affected / 1068 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 1068 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 24 affected / 1068 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 12 affected / 1068 at risk

Adverse event: Respioratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 1068 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1068 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 27 affected / 1068 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 42 affected / 1068 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 64 affected / 1068 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 62 affected / 1068 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 84 affected / 1068 at risk

Adverse event: Vitreous disorder
Serious: no
Organ System: Eye disorders
Frequency: 165 affected / 1068 at risk

Adverse event: Change in bowel habit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 1068 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 1068 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 139 affected / 1068 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 1068 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 69 affected / 1068 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 103 affected / 1079 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 1079 at risk

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 1079 at risk

Adverse event: Ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1079 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 46 affected / 1079 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 1079 at risk

Adverse event: Immune system disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 1079 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 99 affected / 1079 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 66 affected / 1079 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 12 affected / 1079 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 1079 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 85 affected / 1079 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: 92 affected / 1079 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 73 affected / 1079 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 9 affected / 1079 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 25 affected / 1079 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 1079 at risk

Adverse event: Respioratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 1079 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 1079 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 32 affected / 1079 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 42 affected / 1079 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 62 affected / 1079 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 82 affected / 1079 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 88 affected / 1079 at risk

Adverse event: Vitreous disorder
Serious: no
Organ System: Eye disorders
Frequency: 162 affected / 1079 at risk

Adverse event: Change in bowel habit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 1079 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 1079 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 138 affected / 1079 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 73 affected / 1079 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 73 affected / 1079 at risk