Study: NCT00335322

Adverse event: Autoimmune disorder
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 115 at risk

Adverse event: Cervix disorder
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 115 at risk

Adverse event: decreased blood pressure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Fatal outcome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 115 at risk

Adverse event: infection class unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 115 at risk

Adverse event: Injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Investigations, imaging and histopathology
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 115 at risk

Adverse event: Respiratory disorder NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Therapeutic procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 115 at risk

Adverse event: Vascular hemorrhagic disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 115 at risk

Adverse event: Allergic conditions
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 115 at risk

Adverse event: Allergic condition
Serious: no
Organ System: Immune system disorders
Frequency: 11 affected / 115 at risk

Adverse event: Body temperature disorders
Serious: no
Organ System: General disorders
Frequency: 13 affected / 115 at risk

Adverse event: Bacterial infections
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 115 at risk

Adverse event: Reduced blood pressure disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 36 affected / 115 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 115 at risk

Adverse event: Fungal infections
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 115 at risk

Adverse event: Gastrointestinal motility and defaecation disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 115 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 115 at risk

Adverse event: General systems disorder
Serious: no
Organ System: General disorders
Frequency: 17 affected / 115 at risk

Adverse event: headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 115 at risk

Adverse event: heaptic and hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 115 at risk

Adverse event: Infections - pathogennot specified
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 115 at risk

Adverse event: Musculoskeletal and connective tissue disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 115 at risk

Adverse event: Respiratory disroder NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 115 at risk

Adverse event: Sleep disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 115 at risk

Adverse event: Viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 115 at risk

Adverse event: Epidermal and dermal disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 115 at risk

Adverse event: General systems disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: infection class unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 105 at risk

Adverse event: Seizure
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 105 at risk

Adverse event: Venous varices
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: cardiac arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Gastrointestinal motility and defaecation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hepatic and heaptobiliary disroders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Mycobacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 105 at risk

Adverse event: Allergic condition
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 105 at risk

Adverse event: Body temperature disorders
Serious: no
Organ System: General disorders
Frequency: 8 affected / 105 at risk

Adverse event: Bacterial infections
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 105 at risk

Adverse event: Reduced blood pressure disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 105 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 105 at risk

Adverse event: Fungal infections
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 105 at risk

Adverse event: Gastrointestinal motility and defaecation disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 105 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 105 at risk

Adverse event: General systems disorder
Serious: no
Organ System: General disorders
Frequency: 15 affected / 105 at risk

Adverse event: headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 105 at risk

Adverse event: heaptic and hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 46 affected / 105 at risk

Adverse event: Infections - pathogennot specified
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 105 at risk

Adverse event: Musculoskeletal and connective tissue disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 105 at risk

Adverse event: Respiratory disroder NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 105 at risk

Adverse event: Sleep disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 105 at risk

Adverse event: Viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 105 at risk

Adverse event: Epidermal and dermal disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 105 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: decreased blood pressure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: General systems disorder
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 103 at risk

Adverse event: infection class unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: maternal complications of pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 103 at risk

Adverse event: Ovarian and fallopian tube disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pleural disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Respiratory disorder NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Vascular hemorrhagic disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 103 at risk

Adverse event: Viral infectious disorder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Depressed mood and disturbance
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 103 at risk

Adverse event: Anemias and marrow depression
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Hematological and lymphoid tissue therapeutic procedures
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 103 at risk

Adverse event: Allergic condition
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 103 at risk

Adverse event: Body temperature disorders
Serious: no
Organ System: General disorders
Frequency: 6 affected / 103 at risk

Adverse event: Bacterial infections
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 103 at risk

Adverse event: Reduced blood pressure disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 103 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 103 at risk

Adverse event: Fungal infections
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 103 at risk

Adverse event: Gastrointestinal motility and defaecation disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 103 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 103 at risk

Adverse event: General systems disorder
Serious: no
Organ System: General disorders
Frequency: 15 affected / 103 at risk

Adverse event: headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 103 at risk

Adverse event: heaptic and hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Infections - pathogennot specified
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 103 at risk

Adverse event: Musculoskeletal and connective tissue disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 103 at risk

Adverse event: Respiratory disroder NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 103 at risk

Adverse event: Sleep disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 103 at risk

Adverse event: Viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 103 at risk

Adverse event: Epidermal and dermal disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 103 at risk