Study: NCT01252953

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 188 affected / 15225 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2568 affected / 15225 at risk

Adverse event: Congenital, familial and genetic disorders
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 9 affected / 15225 at risk

Adverse event: Ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 114 affected / 15225 at risk

Adverse event: Endocrine disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 50 affected / 15225 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: Eye disorders
Frequency: 204 affected / 15225 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 813 affected / 15225 at risk

Adverse event: General disorders & administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 691 affected / 15225 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 217 affected / 15225 at risk

Adverse event: Immune system disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 12 affected / 15225 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 1559 affected / 15225 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 753 affected / 15225 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 1105 affected / 15225 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 642 affected / 15225 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 438 affected / 15225 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cycts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1323 affected / 15225 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1399 affected / 15225 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 104 affected / 15225 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 415 affected / 15225 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 49 affected / 15225 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 606 affected / 15225 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 84 affected / 15225 at risk

Adverse event: Social circumstances
Serious: yes
Organ System: Social circumstances
Frequency: 501 affected / 15225 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3409 affected / 15225 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 346 affected / 15225 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 169 affected / 3048 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 227 affected / 3048 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 596 affected / 3048 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 321 affected / 3048 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 974 affected / 3048 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 480 affected / 3048 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 327 affected / 3048 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 405 affected / 3048 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1125 affected / 3048 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 625 affected / 3048 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 155 affected / 3048 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 160 affected / 3048 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 463 affected / 3048 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 203 affected / 3048 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 211 affected / 3048 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 185 affected / 3048 at risk

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 182 affected / 15224 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2766 affected / 15224 at risk

Adverse event: Congenital, familial and genetic disorders
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 15224 at risk

Adverse event: Ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 91 affected / 15224 at risk

Adverse event: Endocrine disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 49 affected / 15224 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: Eye disorders
Frequency: 232 affected / 15224 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 788 affected / 15224 at risk

Adverse event: General disorders & administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 736 affected / 15224 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 238 affected / 15224 at risk

Adverse event: Immune system disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 29 affected / 15224 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 1537 affected / 15224 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 777 affected / 15224 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 1135 affected / 15224 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 687 affected / 15224 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 432 affected / 15224 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cycts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1295 affected / 15224 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1455 affected / 15224 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 111 affected / 15224 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 398 affected / 15224 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 56 affected / 15224 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 605 affected / 15224 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 97 affected / 15224 at risk

Adverse event: Social circumstances
Serious: yes
Organ System: Social circumstances
Frequency: 516 affected / 15224 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3478 affected / 15224 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 352 affected / 15224 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 208 affected / 3034 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 230 affected / 3034 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 557 affected / 3034 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 338 affected / 3034 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 943 affected / 3034 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 516 affected / 3034 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 307 affected / 3034 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 393 affected / 3034 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1105 affected / 3034 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 623 affected / 3034 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 139 affected / 3034 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 171 affected / 3034 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 412 affected / 3034 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 211 affected / 3034 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 202 affected / 3034 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 189 affected / 3034 at risk