Study: NCT00279305

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 57 at risk

Adverse event: Dermatology/Skin Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Endocrine- other
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 57 at risk

Adverse event: Gastrointestinal Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Infection with unknown ANC- Sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 57 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 57 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 57 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 57 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 57 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 57 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 57 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 57 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 57 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 57 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 57 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 57 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 57 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 57 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 57 at risk

Adverse event: Dental: teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 57 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 57 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 57 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 57 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 57 at risk

Adverse event: Pelvis Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 57 at risk

Adverse event: Skin Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 57 at risk

Adverse event: Pharynx Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 57 at risk

Adverse event: Sinus Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 57 at risk

Adverse event: Upper Airway Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 57 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 57 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 57 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 57 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 57 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 57 at risk

Adverse event: Sinus pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 57 at risk

Adverse event: Other AE
Serious: no
Organ System: General disorders
Frequency: 5 affected / 57 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 57 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 57 at risk

Adverse event: Edema, larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 57 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Sexual/Reproductive Function - Other
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 57 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 4 affected / 57 at risk

Adverse event: Vascular - Other
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 57 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Endocrine- other
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 30 at risk

Adverse event: Infection Other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Infection with unknown ANC- pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Intra-operative Injury - Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 30 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Blood/Bone Marrow - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 30 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 30 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 30 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Endocrine - Other
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Pelvis Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Skin Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Pharynx Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 30 at risk

Adverse event: Sinus Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Upper Airway Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 30 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 30 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 30 at risk

Adverse event: Sinus pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 30 at risk

Adverse event: Other AE
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk