Study: NCT00255190

Adverse event: Cholecystitis and Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 153 at risk

Adverse event: Abdominal and Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 153 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Leukaemias Acute Myeloid
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 153 at risk

Adverse event: Uterine Neoplasms Benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 153 at risk

Adverse event: Disturbances in Consciousness NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Migraine Headaches
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Bronchospasm and Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 153 at risk

Adverse event: Flatulence, Bloating, and Distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 153 at risk

Adverse event: Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 153 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 153 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 153 at risk

Adverse event: Musculoskeletal and Connective Tissue Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 153 at risk

Adverse event: Headaches NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 153 at risk

Adverse event: Neutropenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Inner Ear Signs and Symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 438 at risk

Adverse event: Duodenal and Small Intestinal Stenosis and Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Pain and Discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 438 at risk

Adverse event: Cholecystitis and Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 438 at risk

Adverse event: Anaphylactic Responses
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Staphylococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Lower Limb Fractures and Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 438 at risk

Adverse event: Non-Site Specific Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 438 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 438 at risk

Adverse event: Thoracic Cage Fractures and Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 438 at risk

Adverse event: Upper Limb Fractures and Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 438 at risk

Adverse event: Intervertebral Disc Disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 438 at risk

Adverse event: Joint Related Disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 438 at risk

Adverse event: B-cell Lymphomas NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 438 at risk

Adverse event: Neoplasms Benign Site Unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 438 at risk

Adverse event: Renal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 438 at risk

Adverse event: Disturbances in Consciousness NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Perception Disturbances
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 438 at risk

Adverse event: Renal Lithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Pneumothorax and Pleural Effusions NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Pulmonary Thrombotic and Embolic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 438 at risk

Adverse event: Flatulence, Bloating, and Distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 438 at risk

Adverse event: Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 438 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 438 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 59 affected / 438 at risk

Adverse event: Musculoskeletal and Connective Tissue Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 438 at risk

Adverse event: Headaches NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 438 at risk