Study: NCT00078897

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 685 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 685 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 48 affected / 685 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 685 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 685 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 685 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 685 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 685 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 685 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 685 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 685 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 685 at risk

Adverse event: Arthritis/Degenerative joint disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 685 at risk

Adverse event: Stroke/Transient ischemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 685 at risk

Adverse event: Atrial fibrillation/arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 685 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 685 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 685 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 685 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 685 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 685 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 685 at risk

Adverse event: Syncope/dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 685 at risk

Adverse event: Misc. cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 685 at risk

Adverse event: Misc. GI disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 685 at risk

Adverse event: Misc. ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 685 at risk

Adverse event: Misc. nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 685 at risk

Adverse event: Misc. psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 685 at risk

Adverse event: Misc. reproductive and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 685 at risk

Adverse event: Misc. vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 685 at risk

Adverse event: Misc. renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 685 at risk

Adverse event: Misc. hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 685 at risk

Adverse event: Misc. metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 685 at risk

Adverse event: Misc. respiratory disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 685 at risk

Adverse event: Misc. musculoskeletal disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 685 at risk

Adverse event: Miscellaneous
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 685 at risk

Adverse event: Misc. neoplasms
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 685 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 685 at risk

Adverse event: Misc. endocrine disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 685 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 689 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 689 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 689 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 689 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 67 affected / 689 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 689 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 689 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 689 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 689 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 689 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 689 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 689 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 689 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 689 at risk

Adverse event: Arthritis/Degenerative joint disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 689 at risk

Adverse event: Stroke/Transient ischemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 689 at risk

Adverse event: Atrial fibrillation/arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 689 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 689 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 689 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 689 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 689 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 689 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 689 at risk

Adverse event: Syncope/dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 689 at risk

Adverse event: Misc. cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 689 at risk

Adverse event: Misc. GI disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 689 at risk

Adverse event: Misc. ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 689 at risk

Adverse event: Misc. nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 689 at risk

Adverse event: Misc. psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 689 at risk

Adverse event: Misc. reproductive and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 689 at risk

Adverse event: Misc. vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 689 at risk

Adverse event: Misc. renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 14 affected / 689 at risk

Adverse event: Misc. hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 689 at risk

Adverse event: Misc. metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 689 at risk

Adverse event: Misc. respiratory disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 689 at risk

Adverse event: Misc. musculoskeletal disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 689 at risk

Adverse event: Miscellaneous
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 689 at risk

Adverse event: Misc. neoplasms
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 689 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 689 at risk

Adverse event: Misc. endocrine disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 689 at risk