Study: NCT00531427

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 282 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 282 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessment One subject experienced bradycardia poststudy
Frequency: 2 affected / 282 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessment
Frequency: 2 affected / 282 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 282 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 282 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 282 at risk

Adverse event: Noncardiac chest pain
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 282 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 282 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 282 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 282 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 282 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 282 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 282 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 282 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessments One subject experienced acute myocardial infarction poststudy
Frequency: 1 affected / 282 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Notes: Poststudy SAE
Frequency: 1 affected / 282 at risk

Adverse event: Small cell lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Poststudy SAE
Frequency: 1 affected / 282 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Poststudy SAE
Frequency: 1 affected / 282 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Poststudy SAE
Frequency: 1 affected / 282 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 34 affected / 282 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 19 affected / 282 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 19 affected / 282 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 31 affected / 282 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 21 affected / 282 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 16 affected / 282 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 7 affected / 282 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 7 affected / 282 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 10 affected / 282 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 18 affected / 282 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessment
Frequency: 16 affected / 282 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 285 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 285 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 285 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 285 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 285 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 14 affected / 285 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 5 affected / 285 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 2 affected / 285 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 18 affected / 285 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 14 affected / 285 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 10 affected / 285 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 3 affected / 285 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 6 affected / 285 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 5 affected / 285 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 20 affected / 285 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessment
Frequency: 2 affected / 285 at risk

Adverse event: Arteriosclerosis coronary artery - DEATH
Serious: yes
Organ System: Cardiac disorders
Notes: DEATH Systematic and nonsystematic assessment
Frequency: 1 affected / 1151 at risk

Adverse event: Hypertensive heart disease - DEATH
Serious: yes
Organ System: Cardiac disorders
Notes: DEATH Systematic and nonsystematic assessment
Frequency: 1 affected / 1151 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 1151 at risk

Adverse event: Noncardiac chest pain
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 1151 at risk

Adverse event: Cardiac procedure complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 1151 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 1151 at risk

Adverse event: Disorientation
Serious: yes
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 1151 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessments One subject experienced acute myocardial infarction poststudy
Frequency: 1 affected / 1151 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 242 affected / 1151 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 90 affected / 1151 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 90 affected / 1151 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 96 affected / 1151 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 37 affected / 1151 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 37 affected / 1151 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 62 affected / 1151 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 132 affected / 1151 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 119 affected / 1151 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 93 affected / 1151 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessment
Frequency: 12 affected / 1151 at risk