Study: NCT00883129

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 69 at risk

Adverse event: Renal and Bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 69 at risk

Adverse event: Syncope and Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 69 at risk

Adverse event: Hematologic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 69 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 69 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 69 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 69 at risk

Adverse event: Respiratory Events
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 69 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 69 at risk

Adverse event: Medication Reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 69 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 69 at risk

Adverse event: Elective surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 69 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 69 at risk

Adverse event: Immune disorder
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 69 at risk

Adverse event: Vision and hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 69 at risk

Adverse event: Hepatobiliary
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 69 at risk

Adverse event: Procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 69 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 69 at risk

Adverse event: Injury, Poisoning and Procedural
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 69 at risk

Adverse event: Nervous System
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 69 at risk

Adverse event: Reproductive and Breast
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 15 affected / 69 at risk

Adverse event: Metabolism and Nutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 69 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 69 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 69 at risk

Adverse event: Renal and Urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 26 affected / 69 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 31 affected / 69 at risk

Adverse event: Skin and Subcutaneous Tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 69 at risk

Adverse event: Musculoskeletal and Connective Tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 69 at risk

Adverse event: Blood and Lymphatic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 69 at risk

Adverse event: Respiratory and Thoracic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 69 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 69 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 69 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 73 at risk

Adverse event: Renal and Bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 73 at risk

Adverse event: Hematologic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 73 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 73 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 73 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 73 at risk

Adverse event: Respiratory Events
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 73 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 73 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 73 at risk

Adverse event: Immune disorder
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 73 at risk

Adverse event: Vision and hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 73 at risk

Adverse event: Hepatobiliary
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 73 at risk

Adverse event: Procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 73 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 73 at risk

Adverse event: Injury, Poisoning and Procedural
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 73 at risk

Adverse event: Nervous System
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 73 at risk

Adverse event: Reproductive and Breast
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 12 affected / 73 at risk

Adverse event: Metabolism and Nutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 73 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 73 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 73 at risk

Adverse event: Renal and Urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 73 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 33 affected / 73 at risk

Adverse event: Skin and Subcutaneous Tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 73 at risk

Adverse event: Musculoskeletal and Connective Tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 73 at risk

Adverse event: Blood and Lymphatic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 47 affected / 73 at risk

Adverse event: Respiratory and Thoracic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 45 affected / 73 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 73 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 73 at risk