Study: NCT00251693

Adverse event: Coronary Artery Disorders not elsewhere classified (NEC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 680 at risk

Adverse event: Gastrointestinal (GI) Atonic and Hypomotility Disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 680 at risk

Adverse event: Intestinal Ulcers and Perforation NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 680 at risk

Adverse event: Peritoneal and Retroperitoneal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 680 at risk

Adverse event: Pain and Discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 680 at risk

Adverse event: Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 680 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 680 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia and Fungaemia NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 680 at risk

Adverse event: Potassium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 680 at risk

Adverse event: Soft Tissue Disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 680 at risk

Adverse event: Acute Polyneuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 680 at risk

Adverse event: Transient Cerebrovascular (CV) Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 680 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 680 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 680 at risk

Adverse event: Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 680 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 680 at risk

Adverse event: Gastrointestinal Inflammatory Disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 668 at risk

Adverse event: Haemorrhoids and GI Varices (Excluding [Excl] Oesophageal)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 668 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 668 at risk

Adverse event: Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 668 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 668 at risk

Adverse event: Duodenal and Small Intestinal Stenosis and Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 690 at risk

Adverse event: Cholecystitis and Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 690 at risk

Adverse event: Streptococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 690 at risk

Adverse event: Non-site Specfic Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 690 at risk

Adverse event: Paralysis and Paresis (Excl Cranial Nerve)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 690 at risk

Adverse event: Central Nervous System Hemorrhages and CV accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 690 at risk

Adverse event: Bipolar Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 690 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 690 at risk

Adverse event: Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 690 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 690 at risk