Study: NCT01102374

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 55 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 7 affected / 55 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 15 affected / 55 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 6 affected / 55 at risk

Adverse event: Endocrine disorders
Serious: no
Organ System: Endocrine disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 3 affected / 55 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 5 affected / 55 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 22 affected / 55 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 39 affected / 55 at risk

Adverse event: Hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 1 affected / 55 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 9 affected / 55 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 21 affected / 55 at risk

Adverse event: Injury, poisoning, and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 29 affected / 55 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 16 affected / 55 at risk

Adverse event: Metabolic and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 18 affected / 55 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 17 affected / 55 at risk

Adverse event: Neoplasms
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 1 affected / 55 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 10 affected / 55 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 30 affected / 55 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 13 affected / 55 at risk

Adverse event: Reproductive system disorders
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 6 affected / 55 at risk

Adverse event: Respiratory, thoracic, and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 24 affected / 55 at risk

Adverse event: Skin and subcutaneous disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 23 affected / 55 at risk

Adverse event: Social circumstances
Serious: no
Organ System: Social circumstances
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 1 affected / 55 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 14 affected / 55 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 52 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 4 affected / 52 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 9 affected / 52 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 1 affected / 52 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 7 affected / 52 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 27 affected / 52 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 28 affected / 52 at risk

Adverse event: Hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 1 affected / 52 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 7 affected / 52 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 21 affected / 52 at risk

Adverse event: Injury, poisoning, and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 30 affected / 52 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 12 affected / 52 at risk

Adverse event: Metabolic and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 15 affected / 52 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 16 affected / 52 at risk

Adverse event: Neoplasms
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 1 affected / 52 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 10 affected / 52 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 19 affected / 52 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 10 affected / 52 at risk

Adverse event: Reproductive system disorders
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 2 affected / 52 at risk

Adverse event: Respiratory, thoracic, and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 30 affected / 52 at risk

Adverse event: Skin and subcutaneous disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 22 affected / 52 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Notes: Adverse events were recorded at the organ system level using the MedDRA classification system
Frequency: 6 affected / 52 at risk