Study: NCT00174915

Adverse event: Coronary Artery Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 267 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 267 at risk

Adverse event: Gastrointestinal & Abdominal Pain, Excluding Oral,Throat
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Pain and Discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 267 at risk

Adverse event: Device Failure and Malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 267 at risk

Adverse event: Muscle Weakness Conditions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Prostatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 267 at risk

Adverse event: Transient Cerebrovascular Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 267 at risk

Adverse event: Bronchospasm and Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Lower Respiratory Tract Signs and Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Diarrhoea (Excluding Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 267 at risk

Adverse event: Gastrointestinal & Abdominal Pains, Excluding Oral,Throat
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 267 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 267 at risk

Adverse event: Influenza Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 267 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 267 at risk

Adverse event: Non-Site Specific Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 267 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 17 affected / 267 at risk

Adverse event: Joint Related Signs and Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 267 at risk

Adverse event: Muscle Related Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 267 at risk

Adverse event: Musculoskeletal and Connective Tissues Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 267 at risk

Adverse event: Headache NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 267 at risk

Adverse event: Neurological Signs and Symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 267 at risk

Adverse event: Vascular Hypertensive Disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 267 at risk

Adverse event: Anaemias not elsewhere classified (NEC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 269 at risk

Adverse event: Cardiomyopathies
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 269 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 269 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 269 at risk

Adverse event: Pain and Discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 269 at risk

Adverse event: Hypoglycaemic Conditions NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 269 at risk

Adverse event: Colonic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 269 at risk

Adverse event: Endocrine Neoplasms Malignant and Unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 269 at risk

Adverse event: Diarrhoea (Excluding Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 269 at risk

Adverse event: Gastrointestinal & Abdominal Pains, Excluding Oral,Throat
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 269 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 269 at risk

Adverse event: Influenza Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 269 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 269 at risk

Adverse event: Non-Site Specific Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 269 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 10 affected / 269 at risk

Adverse event: Joint Related Signs and Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 269 at risk

Adverse event: Muscle Related Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 269 at risk

Adverse event: Musculoskeletal and Connective Tissues Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 269 at risk

Adverse event: Headache NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 269 at risk

Adverse event: Neurological Signs and Symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 269 at risk

Adverse event: Vascular Hypertensive Disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 269 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Abdominal Hernias, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 134 at risk

Adverse event: Duodenal and Small Intestinal Stenosis and Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 134 at risk

Adverse event: Total Fluid Volume Decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 134 at risk

Adverse event: Seizures and Seizure Disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 134 at risk

Adverse event: Renal Failure and Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 134 at risk

Adverse event: Diarrhoea (Excluding Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 134 at risk

Adverse event: Gastrointestinal & Abdominal Pains, Excluding Oral,Throat
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 134 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 134 at risk

Adverse event: Influenza Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 134 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 134 at risk

Adverse event: Non-Site Specific Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 134 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 6 affected / 134 at risk

Adverse event: Joint Related Signs and Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 134 at risk

Adverse event: Muscle Related Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 134 at risk

Adverse event: Musculoskeletal and Connective Tissues Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 134 at risk

Adverse event: Headache NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 134 at risk

Adverse event: Neurological Signs and Symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 134 at risk

Adverse event: Vascular Hypertensive Disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 134 at risk

Adverse event: Intestinal Ulcers and Perforation NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Pain and Discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 268 at risk

Adverse event: Cholecystitis and Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 268 at risk

Adverse event: Abdominal and Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Endocrine Neoplasms Benign NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Hodgkin's Disease NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Diarrhoea (Excluding Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 268 at risk

Adverse event: Gastrointestinal & Abdominal Pains, Excluding Oral,Throat
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 268 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 268 at risk

Adverse event: Influenza Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 268 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 268 at risk

Adverse event: Non-Site Specific Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 268 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 15 affected / 268 at risk

Adverse event: Joint Related Signs and Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 268 at risk

Adverse event: Muscle Related Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Musculoskeletal and Connective Tissues Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 268 at risk

Adverse event: Headache NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 268 at risk

Adverse event: Neurological Signs and Symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 268 at risk

Adverse event: Vascular Hypertensive Disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 268 at risk

Adverse event: Coronary Artery Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Device Related Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 134 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 134 at risk

Adverse event: Diarrhoea (Excluding Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 134 at risk

Adverse event: Gastrointestinal & Abdominal Pains, Excluding Oral,Throat
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 134 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 134 at risk

Adverse event: Influenza Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 134 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 134 at risk

Adverse event: Non-Site Specific Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 134 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 3 affected / 134 at risk

Adverse event: Joint Related Signs and Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 134 at risk

Adverse event: Muscle Related Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 134 at risk

Adverse event: Musculoskeletal and Connective Tissues Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 134 at risk

Adverse event: Headache NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 134 at risk

Adverse event: Neurological Signs and Symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 134 at risk

Adverse event: Vascular Hypertensive Disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 134 at risk