Study: NCT01767909

Adverse event: BLOOD AND LYMPHATIC SYSTEM DISORDERS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 121 at risk

Adverse event: CARDIAC DISORDERS
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 121 at risk

Adverse event: GASTROINTESTINAL DISORDERS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 121 at risk

Adverse event: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 121 at risk

Adverse event: HEPATOBILIARY DISORDERS
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 121 at risk

Adverse event: INFECTIONS AND INFESTATIONS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 121 at risk

Adverse event: INJURY, POISONING AND PROCEDURAL COMPLICATIONS
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 121 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: 1 affected / 121 at risk

Adverse event: NERVOUS SYSTEM DISORDERS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 121 at risk

Adverse event: PSYCHIATRIC DISORDERS
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 121 at risk

Adverse event: RENAL AND URINARY DISORDERS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 121 at risk

Adverse event: VASCULAR DISORDERS
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 121 at risk

Adverse event: BLOOD AND LYMPHATIC SYSTEM DISORDERS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 121 at risk

Adverse event: CARDIAC DISORDERS
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 121 at risk

Adverse event: ENDOCRINE DISORDERS
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 121 at risk

Adverse event: EYE DISORDERS
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 121 at risk

Adverse event: GASTROINTESTINAL DISORDERS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 121 at risk

Adverse event: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Serious: no
Organ System: General disorders
Frequency: 11 affected / 121 at risk

Adverse event: HEPATOBILIARY DISORDERS
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 121 at risk

Adverse event: IMMUNE SYSTEM DISORDERS
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 121 at risk

Adverse event: INFECTIONS AND INFESTATIONS
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 121 at risk

Adverse event: INJURY, POISONING AND PROCEDURAL COMPLICATIONS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 121 at risk

Adverse event: INVESTIGATIONS
Serious: no
Organ System: Investigations
Frequency: 6 affected / 121 at risk

Adverse event: METABOLISM AND NUTRITION DISORDERS
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 121 at risk

Adverse event: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 121 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: 9 affected / 121 at risk

Adverse event: NERVOUS SYSTEM DISORDERS
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 121 at risk

Adverse event: PSYCHIATRIC DISORDERS
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 121 at risk

Adverse event: RENAL AND URINARY DISORDERS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 121 at risk

Adverse event: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 121 at risk

Adverse event: SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 121 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 121 at risk

Adverse event: VASCULAR DISORDERS
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 121 at risk

Adverse event: CARDIAC DISORDERS
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 119 at risk

Adverse event: GASTROINTESTINAL DISORDERS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: INFECTIONS AND INFESTATIONS
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 119 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: 1 affected / 119 at risk

Adverse event: NERVOUS SYSTEM DISORDERS
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 119 at risk

Adverse event: VASCULAR DISORDERS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 119 at risk

Adverse event: BLOOD AND LYMPHATIC SYSTEM DISORDERS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 119 at risk

Adverse event: CARDIAC DISORDERS
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 119 at risk

Adverse event: DEMENTIA AND AMNESTIC CONDITIONS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: EYE DISORDERS
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 119 at risk

Adverse event: GASTROINTESTINAL DISORDERS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 119 at risk

Adverse event: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Serious: no
Organ System: General disorders
Frequency: 7 affected / 119 at risk

Adverse event: IMMUNE SYSTEM DISORDERS
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 119 at risk

Adverse event: INFECTIONS AND INFESTATIONS
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 119 at risk

Adverse event: INJURY, POISONING AND PROCEDURAL COMPLICATIONS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 30 affected / 119 at risk

Adverse event: INVESTIGATIONS
Serious: no
Organ System: Investigations
Frequency: 4 affected / 119 at risk

Adverse event: METABOLISM AND NUTRITION DISORDERS
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 119 at risk

Adverse event: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 119 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: 6 affected / 119 at risk

Adverse event: NERVOUS SYSTEM DISORDERS
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 119 at risk

Adverse event: PSYCHIATRIC DISORDERS
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 119 at risk

Adverse event: RENAL AND URINARY DISORDERS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 119 at risk

Adverse event: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 119 at risk

Adverse event: SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 119 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 119 at risk

Adverse event: VASCULAR DISORDERS
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 119 at risk