Study: NCT00294684

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: AEs reported with regard to affected organ system
Frequency: 1 affected / 70 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: AEs reported with regard to affected organ system
Frequency: 5 affected / 70 at risk

Adverse event: Hepatic
Serious: yes
Organ System: Hepatobiliary disorders
Notes: AEs reported with regard to affected organ system
Frequency: 22 affected / 70 at risk

Adverse event: Immunological
Serious: yes
Organ System: Immune system disorders
Notes: AEs reported with regard to affected organ system
Frequency: 1 affected / 70 at risk

Adverse event: Infectious
Serious: yes
Organ System: Infections and infestations
Notes: AEs reported with regard to affected organ system
Frequency: 50 affected / 70 at risk

Adverse event: Metabolic
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: AEs reported as Metabolic
Frequency: 1 affected / 70 at risk

Adverse event: Miscellaneous
Serious: yes
Organ System: General disorders
Notes: AEs reported with regard to affected organ system
Frequency: 3 affected / 70 at risk

Adverse event: Neoplastic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: AEs reported with regard to affected organ system
Frequency: 1 affected / 70 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Notes: AEs reported with regard to affected organ system
Frequency: 1 affected / 70 at risk

Adverse event: Nutritional
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: AEs reported as Nutritional
Frequency: 7 affected / 70 at risk

Adverse event: Orthopedic
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: AEs reported with regard to affected organ system
Frequency: 2 affected / 70 at risk

Adverse event: Surgical
Serious: yes
Organ System: Surgical and medical procedures
Notes: AEs reported with regard to affected organ system
Frequency: 7 affected / 70 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: AEs reported with regard to affected organ system
Frequency: 1 affected / 70 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: AEs reported with regard to affected organ system
Frequency: 3 affected / 70 at risk

Adverse event: Hepatic
Serious: yes
Organ System: Hepatobiliary disorders
Notes: AEs reported with regard to affected organ system
Frequency: 16 affected / 70 at risk

Adverse event: Infectious
Serious: yes
Organ System: Infections and infestations
Notes: AEs reported with regard to affected organ system
Frequency: 46 affected / 70 at risk

Adverse event: Metabolic
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: AEs reported as Metabolic
Frequency: 1 affected / 70 at risk

Adverse event: Miscellaneous
Serious: yes
Organ System: General disorders
Notes: AEs reported with regard to affected organ system
Frequency: 1 affected / 70 at risk

Adverse event: Nutritional
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: AEs reported as Nutritional
Frequency: 9 affected / 70 at risk

Adverse event: Orthopedic
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: AEs reported with regard to affected organ system
Frequency: 2 affected / 70 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AEs reported with regard to affected organ system
Frequency: 1 affected / 70 at risk

Adverse event: Surgical
Serious: yes
Organ System: Surgical and medical procedures
Notes: AEs reported with regard to affected organ system
Frequency: 2 affected / 70 at risk