Study: NCT00531453

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: General Disorders and administration site Conditions
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 49 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Respiratory, Thoracic and mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 49 at risk

Adverse event: Blood and Lymphatic System Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Metabolism and Nutritional Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: Renal and Urinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 49 at risk

Adverse event: General Disorders and Administration Site Conditions
Serious: no
Organ System: General disorders
Frequency: 28 affected / 49 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 49 at risk

Adverse event: Blood and Lymphatic System Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 49 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 49 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 49 at risk

Adverse event: Metabolism and Nutrition Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 49 at risk

Adverse event: Skin and Subcutaneous Tissue Disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 49 at risk

Adverse event: Respiratory, Thoracic and Mediastinal Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 49 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 49 at risk

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 49 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 49 at risk

Adverse event: Hepatobiliary Disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 49 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 2 affected / 49 at risk

Adverse event: Ear and labyrinth Disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 49 at risk

Adverse event: Injury, Poisoning and Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Renal and Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 49 at risk

Adverse event: Endocrine Disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 49 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 49 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: General Disorders and administration site Conditions
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 49 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 49 at risk

Adverse event: Respiratory, Thoracic and mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Blood and Lymphatic System Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: Injury, Poisoning and Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 49 at risk

Adverse event: Metabolism and Nutritional Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: Psychiatric Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: Skin and Subcutaneous Tissue Disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 49 at risk

Adverse event: General Disorders and Administration Site Conditions
Serious: no
Organ System: General disorders
Frequency: 28 affected / 49 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 49 at risk

Adverse event: Blood and Lymphatic System Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 49 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 49 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 49 at risk

Adverse event: Metabolism and Nutrition Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 49 at risk

Adverse event: Skin and Subcutaneous Tissue Disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 49 at risk

Adverse event: Respiratory, Thoracic and Mediastinal Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 49 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 49 at risk

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 49 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 49 at risk

Adverse event: Hepatobiliary Disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 49 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 49 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 5 affected / 49 at risk

Adverse event: Ear and labyrinth Disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 49 at risk

Adverse event: Injury, Poisoning and Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 49 at risk

Adverse event: Renal and Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 49 at risk

Adverse event: Immune System Disorders
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Neoplasms Benign, Malignant and Unspecified
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 49 at risk

Adverse event: Reproductive System and Brest Disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk