Study: NCT00113087

Adverse event: Cardiac general
Serious: yes
Organ System: Cardiac disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 29 affected / 115 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 36 affected / 115 at risk

Adverse event: Neurology
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 115 at risk

Adverse event: Pulmonary/Upper Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 115 at risk

Adverse event: Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 22 affected / 115 at risk

Adverse event: blood/bone marrow
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 4 affected / 115 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 4 affected / 115 at risk

Adverse event: coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 1 affected / 115 at risk

Adverse event: constitutional symptoms
Serious: yes
Organ System: General disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 2 affected / 115 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 5 affected / 115 at risk

Adverse event: dermatology/skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 1 affected / 115 at risk

Adverse event: gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 20 affected / 115 at risk

Adverse event: growth and development
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 1 affected / 115 at risk

Adverse event: hemorrhage/bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 1 affected / 115 at risk

Adverse event: lymphatics
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 1 affected / 115 at risk

Adverse event: metabolic/laboratory
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 3 affected / 115 at risk

Adverse event: musculoskeletal/soft issue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 1 affected / 115 at risk

Adverse event: renal/genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 1 affected / 115 at risk

Adverse event: Cardiac General
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 115 at risk

Adverse event: Neurology
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 115 at risk

Adverse event: Pulmonary/upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 115 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 115 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 115 at risk

Adverse event: allergy/immunology
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 115 at risk

Adverse event: blood/bone marrow
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 115 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 115 at risk

Adverse event: coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: constitutional symptoms
Serious: no
Organ System: General disorders
Frequency: 8 affected / 115 at risk

Adverse event: dermatology/skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 115 at risk

Adverse event: endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 115 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 115 at risk

Adverse event: hemorrhage/bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: hepatobillary
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 115 at risk

Adverse event: metabolic/laboratory
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 115 at risk

Adverse event: renal/genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 115 at risk

Adverse event: surgery/intra-operative injury
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 115 at risk

Adverse event: growth and development
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 115 at risk

Adverse event: musculoskeletal/soft tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Cardiac general
Serious: yes
Organ System: Cardiac disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 19 affected / 115 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 35 affected / 115 at risk

Adverse event: Neurology
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 115 at risk

Adverse event: Pulmonary/Upper Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 115 at risk

Adverse event: Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 21 affected / 115 at risk

Adverse event: auditory/ear
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 1 affected / 115 at risk

Adverse event: blood/bone marrow
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 2 affected / 115 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 5 affected / 115 at risk

Adverse event: constitutional symptoms
Serious: yes
Organ System: General disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 3 affected / 115 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 4 affected / 115 at risk

Adverse event: dermatology/skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 1 affected / 115 at risk

Adverse event: gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 18 affected / 115 at risk

Adverse event: growth and development
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 5 affected / 115 at risk

Adverse event: hemorrhage/bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 2 affected / 115 at risk

Adverse event: musculoskeletal/soft issue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 2 affected / 115 at risk

Adverse event: renal/genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 1 affected / 115 at risk

Adverse event: surgery/intra-operative injury
Serious: yes
Organ System: Surgical and medical procedures
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 3 affected / 115 at risk

Adverse event: syndromes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Adjudication by independent medical monitor for all serious adverse events
Frequency: 1 affected / 115 at risk

Adverse event: Cardiac General
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 115 at risk

Adverse event: Neurology
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 115 at risk

Adverse event: Pulmonary/upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 115 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 115 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 115 at risk

Adverse event: allergy/immunology
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 115 at risk

Adverse event: auditory/ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 115 at risk

Adverse event: blood/bone marrow
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 115 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 115 at risk

Adverse event: coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: constitutional symptoms
Serious: no
Organ System: General disorders
Frequency: 3 affected / 115 at risk

Adverse event: dermatology/skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 115 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 115 at risk

Adverse event: hemorrhage/bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: metabolic/laboratory
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 115 at risk

Adverse event: renal/genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 115 at risk

Adverse event: musculoskeletal/soft tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 115 at risk