Study: NCT00372411

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 49 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 49 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Respite care
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 49 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Notes: Sum of all adverse event terms in the Cardiac Disorders System Organ Class
Frequency: 1 affected / 49 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Notes: Sum of all adverse event terms in the General Disorders System Organ Class
Frequency: 1 affected / 49 at risk

Adverse event: Hepatobiliary Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Sum of all adverse event terms in the Hepatobiliary Disorders System Organ Class
Frequency: 2 affected / 49 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Notes: Sum of all adverse event terms in the Infections and Infestations System Organ Class
Frequency: 3 affected / 49 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Sum of all adverse event terms in the Injury, Poisoning and Procedural Complications System Organ Class
Frequency: 3 affected / 49 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Notes: Sum of all adverse event terms in the Nervous System Disorders System Organ Class
Frequency: 2 affected / 49 at risk

Adverse event: Renal and Urinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Notes: Sum of all adverse event terms in the Renal and Urinary Disorders System Organ Class
Frequency: 1 affected / 49 at risk

Adverse event: Social Circumstances
Serious: yes
Organ System: Social circumstances
Notes: Sum of all adverse event terms in the Social Circumstances System Organ Class
Frequency: 1 affected / 49 at risk

Adverse event: Pain, Stiffness, or Soreness
Serious: no
Organ System: General disorders
Notes: Only related adverse event were collected. Pain, stiffness, or soreness collected as a single type of event
Frequency: 10 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue related to study therapy.
Frequency: 3 affected / 49 at risk

Adverse event: Swelling or Bruising
Serious: no
Organ System: General disorders
Notes: Swelling or Bruising collected as one event related to study therapy.
Frequency: 1 affected / 49 at risk

Adverse event: Cut, Scratch or Irritation
Serious: no
Organ System: General disorders
Notes: Cut, Scratch or Irritation related to study therapy collected as one event type.
Frequency: 2 affected / 49 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: General disorders
Notes: Numbness related to study therapy.
Frequency: 2 affected / 49 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 50 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 50 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 50 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 50 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 50 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Respite care
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 50 at risk

Adverse event: Cardiac pacemaker replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 50 at risk

Adverse event: Hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 50 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Notes: Sum of all adverse event terms in the Cardiac Disorders System Organ Class
Frequency: 2 affected / 50 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Sum of all adverse event terms in the Gastrointestinal Disorders System Organ Class
Frequency: 3 affected / 50 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Notes: Sum of all adverse event terms in the General Disorders System Organ Class
Frequency: 2 affected / 50 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Notes: Sum of all adverse event terms in the Infections and Infestations System Organ Class
Frequency: 2 affected / 50 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Sum of all adverse event terms in the Injury, Poisoning and Procedural Complications System Organ Class
Frequency: 4 affected / 50 at risk

Adverse event: Neoplasms
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Sum of all adverse event terms in the Neoplasms System Organ Class
Frequency: 2 affected / 50 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Notes: Sum of all adverse event terms in the Nervous System Disorders System Organ Class
Frequency: 2 affected / 50 at risk

Adverse event: Psychiatric Disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Sum of all adverse event terms in the Psychiatric Disorders System Organ Class
Frequency: 1 affected / 50 at risk

Adverse event: Respiratory Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sum of all adverse event terms in the Respiratory Disorders System Organ Class
Frequency: 1 affected / 50 at risk

Adverse event: Social Circumstances
Serious: yes
Organ System: Social circumstances
Notes: Sum of all adverse event terms in the Social Circumstances System Organ Class
Frequency: 1 affected / 50 at risk

Adverse event: Surgical and Medical Procedures
Serious: yes
Organ System: Surgical and medical procedures
Notes: Sum of all adverse event terms in the Surgical and Medical Procedures System Organ Class
Frequency: 2 affected / 50 at risk

Adverse event: Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Notes: Sum of all adverse event terms in the Vascular Disorders System Organ Class
Frequency: 2 affected / 50 at risk

Adverse event: Pain, Stiffness, or Soreness
Serious: no
Organ System: General disorders
Notes: Only related adverse event were collected. Pain, stiffness, or soreness collected as a single type of event
Frequency: 6 affected / 50 at risk

Adverse event: Swelling or Bruising
Serious: no
Organ System: General disorders
Notes: Swelling or Bruising collected as one event related to study therapy.
Frequency: 1 affected / 50 at risk

Adverse event: Cut, Scratch or Irritation
Serious: no
Organ System: General disorders
Notes: Cut, Scratch or Irritation related to study therapy collected as one event type.
Frequency: 2 affected / 50 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Drug interaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 28 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 28 at risk

Adverse event: Neurogenic bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Respite care
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 28 at risk

Adverse event: Large intestinal polypectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 28 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 28 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 28 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Notes: Sum of all adverse event terms in the Cardiac Disorders System Organ Class
Frequency: 3 affected / 28 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Notes: Sum of all adverse event terms in the General Disorders System Organ Class
Frequency: 1 affected / 28 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Notes: Sum of all adverse event terms in the Infections and Infestations System Organ Class
Frequency: 1 affected / 28 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Sum of all adverse event terms in the Injury, Poisoning and Procedural Complications System Organ Class
Frequency: 1 affected / 28 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Notes: Sum of all adverse event terms in the Nervous System Disorders System Organ Class
Frequency: 1 affected / 28 at risk

Adverse event: Psychiatric Disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Sum of all adverse event terms in the Psychiatric Disorders System Organ Class
Frequency: 1 affected / 28 at risk

Adverse event: Renal and Urinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Notes: Sum of all adverse event terms in the Renal and Urinary Disorders System Organ Class
Frequency: 2 affected / 28 at risk

Adverse event: Respiratory Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sum of all adverse event terms in the Respiratory Disorders System Organ Class
Frequency: 1 affected / 28 at risk

Adverse event: Social Circumstances
Serious: yes
Organ System: Social circumstances
Notes: Sum of all adverse event terms in the Social Circumstances System Organ Class
Frequency: 1 affected / 28 at risk

Adverse event: Surgical and Medical Procedures
Serious: yes
Organ System: Surgical and medical procedures
Notes: Sum of all adverse event terms in the Surgical and Medical Procedures System Organ Class
Frequency: 2 affected / 28 at risk

Adverse event: Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Notes: Sum of all adverse event terms in the Vascular Disorders System Organ Class
Frequency: 1 affected / 28 at risk