Study: NCT00530764

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 90 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Notes: Any new unfavorable/unintended symptoms, worsening of condition that may/not be considered related to study medication.
Frequency: 4 affected / 90 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 90 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: Metabolism and Nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 90 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: 13 affected / 90 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 90 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 90 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 90 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 90 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 90 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 90 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 90 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 90 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 90 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Frequency: 24 affected / 90 at risk

Adverse event: Hepatobillary Disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 90 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 90 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 5 affected / 90 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 90 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 90 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: 16 affected / 90 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 90 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 90 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 90 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 90 at risk

Adverse event: Skin and subcuraneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 90 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 90 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 87 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Notes: Any new unfavorable/unintended symptoms, worsening of condition that may/not be considered related to study medication.
Frequency: 1 affected / 87 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 87 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 87 at risk

Adverse event: Injury, Poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 87 at risk

Adverse event: Metabolism and Nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 87 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: 12 affected / 87 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 87 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 87 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 87 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 87 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 87 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 87 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 87 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 87 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Frequency: 18 affected / 87 at risk

Adverse event: Hepatobillary Disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 87 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 87 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 87 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 9 affected / 87 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 87 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 87 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 / 87 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 87 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 87 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 87 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 87 at risk

Adverse event: Skin and subcuraneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 87 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 87 at risk

Adverse event: Blood and Lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 91 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Notes: Any new unfavorable/unintended symptoms, worsening of condition that may/not be considered related to study medication.
Frequency: 4 affected / 91 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 91 at risk

Adverse event: Injury, Poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 91 at risk

Adverse event: Metabolism and Nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 87 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: 26 affected / 91 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 91 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 91 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 91 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 91 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 91 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 91 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Frequency: 18 affected / 91 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 81 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 11 affected / 91 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 91 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 91 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: 26 affected / 91 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 91 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 91 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 91 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 91 at risk

Adverse event: Skin and subcuraneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 91 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 91 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 91 at risk

Adverse event: Blood and Lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 91 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 91 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 91 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Notes: Any new unfavorable/unintended symptoms, worsening of condition that may/not be considered related to study medication.
Frequency: 2 affected / 91 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 91 at risk

Adverse event: Injury, Poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 91 at risk

Adverse event: Metabolism and Nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 91 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 91 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: 15 affected / 91 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 91 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 91 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 91 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 91 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 91 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 91 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 91 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Frequency: 20 affected / 91 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 91 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 91 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 3 affected / 91 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 91 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 91 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: 14 affected / 91 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 91 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 91 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 91 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 91 at risk

Adverse event: Skin and subcuraneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 91 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 91 at risk