Study: NCT00110812

Adverse event: Bladder and urethral symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 87 at risk

Adverse event: Diarrhoea (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 87 at risk

Adverse event: Febrile disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 87 at risk

Adverse event: Non-site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 87 at risk

Adverse event: Renal failure and impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 87 at risk

Adverse event: Salivary gland disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 87 at risk

Adverse event: Coronary artery disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 87 at risk

Adverse event: Febrile disorders
Serious: no
Organ System: General disorders
Frequency: 7 affected / 87 at risk

Adverse event: Bacterial infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 89 at risk

Adverse event: Bronchospasm and obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Calcium metabolism disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 89 at risk

Adverse event: Ear infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: General nutritional disorders NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 89 at risk

Adverse event: Hyperparathyroid disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 89 at risk

Adverse event: Male reproductive tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Epstein-Barr viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Febrile disorders
Serious: no
Organ System: General disorders
Frequency: 3 affected / 89 at risk

Adverse event: Anaemias NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 91 at risk

Adverse event: Bronchospasm and obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: Cholecystitis and cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 91 at risk

Adverse event: Gastrointestinal atonic and hypomotility disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: Abdominal and gastrointestinal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 91 at risk

Adverse event: Renal failure and impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 91 at risk

Adverse event: Central nervous sytem haemorrhages and cerebrovascular accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 91 at risk

Adverse event: Chemical injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 91 at risk

Adverse event: Depressive disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 91 at risk

Adverse event: Pulmonary thrombotic and embolic conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: Sepsis, bacteraemia, viraemia and fungaemia NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 91 at risk

Adverse event: Abdominal and gastrointestinal infections
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 91 at risk