Study: NCT00461630

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 84 affected / 12838 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1937 affected / 12838 at risk

Adverse event: Congenital, familial, genetic disorders
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 28 affected / 12838 at risk

Adverse event: Ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 52 affected / 12838 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: Eye disorders
Frequency: 50 affected / 12838 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 620 affected / 12838 at risk

Adverse event: General disorders
Serious: yes
Organ System: General disorders
Frequency: 346 affected / 12838 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 163 affected / 12838 at risk

Adverse event: Immune system disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 20 affected / 12838 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 1031 affected / 12838 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 456 affected / 12838 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 1210 affected / 12838 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 961 affected / 12838 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 446 affected / 12838 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: 751 affected / 12838 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1067 affected / 12838 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 68 affected / 12838 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 208 affected / 12838 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 41 affected / 12838 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 358 affected / 12838 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 86 affected / 12838 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2721 affected / 12838 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 258 affected / 12838 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 35 affected / 12838 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 12838 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 48 affected / 12838 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1168 affected / 12838 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Frequency: 176 affected / 12838 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 218 affected / 12838 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 439 affected / 12838 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 545 affected / 12838 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 213 affected / 12838 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 112 affected / 12838 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 42 affected / 12838 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 75 affected / 12838 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1835 affected / 12838 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Notes: Only non-serious adverse events considered by participant to be related to study treatment recorded
Frequency: 927 affected / 12838 at risk

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 56 affected / 12835 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1925 affected / 12835 at risk

Adverse event: Congenital, familial, genetic disorders
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 19 affected / 12835 at risk

Adverse event: Ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 40 affected / 12835 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: Eye disorders
Frequency: 75 affected / 12835 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 491 affected / 12835 at risk

Adverse event: General disorders
Serious: yes
Organ System: General disorders
Frequency: 300 affected / 12835 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 140 affected / 12835 at risk

Adverse event: Immune system disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 25 affected / 12835 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 853 affected / 12835 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 400 affected / 12835 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 1108 affected / 12835 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 703 affected / 12835 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 364 affected / 12835 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: 749 affected / 12835 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1086 affected / 12835 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 65 affected / 12835 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 188 affected / 12835 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 40 affected / 12835 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 307 affected / 12835 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 51 affected / 12835 at risk

Adverse event: Social circumstances
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 12835 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2722 affected / 12835 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 246 affected / 12835 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 12835 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 12835 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 27 affected / 12835 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 690 affected / 12835 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Frequency: 138 affected / 12835 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 132 affected / 12835 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 270 affected / 12835 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 516 affected / 12835 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 179 affected / 12835 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 82 affected / 12835 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 38 affected / 12835 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 12835 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 51 affected / 12835 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 580 affected / 12835 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Notes: Only non-serious adverse events considered by participant to be related to study treatment recorded
Frequency: 123 affected / 12835 at risk