Study: NCT00006392

Adverse event: Arrhythmia, NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 8752 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 8752 at risk

Adverse event: Cardiovascular-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 8752 at risk

Adverse event: LVEF decrease/CHF
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 8752 at risk

Adverse event: Supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 8752 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 8752 at risk

Adverse event: Melena/ GI bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Reportable adverse event, NOS
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 8752 at risk

Adverse event: Liver-other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Respiratory infect w/o neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 8752 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Second primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 8752 at risk

Adverse event: CNS hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 8752 at risk

Adverse event: Cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 8752 at risk

Adverse event: Neuro-other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Erectile impotence
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Emphysema/COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 8752 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 8752 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 8752 at risk

Adverse event: Cardiac ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 558 affected / 8752 at risk

Adverse event: Breath odour
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 523 affected / 8752 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 698 affected / 8752 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 647 affected / 8752 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1129 affected / 8752 at risk

Adverse event: Arrhythmia, NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 8702 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 8702 at risk

Adverse event: Cardiovascular-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 8702 at risk

Adverse event: Conduction abnormality/block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8702 at risk

Adverse event: LVEF decrease/CHF
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 8702 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 8702 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8702 at risk

Adverse event: Melena/ GI bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8702 at risk

Adverse event: Rectal bleeding/hematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8702 at risk

Adverse event: Reportable adverse event, NOS
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 8702 at risk

Adverse event: Respiratory infect w/o neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8702 at risk

Adverse event: Urinary tr infect w/o neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8702 at risk

Adverse event: Second primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 8702 at risk

Adverse event: CNS hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 8702 at risk

Adverse event: Cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 17 affected / 8702 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8702 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8702 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8702 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8702 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8702 at risk

Adverse event: Carotid stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 8702 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 8702 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 8702 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 8702 at risk

Adverse event: Cardiac ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 533 affected / 8702 at risk

Adverse event: Breath odour
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 555 affected / 8702 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 657 affected / 8702 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 593 affected / 8702 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1080 affected / 8702 at risk

Adverse event: Arrhythmia, NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 8696 at risk

Adverse event: Cardiovascular-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 8696 at risk

Adverse event: Conduction abnormality/block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8696 at risk

Adverse event: LVEF decrease/CHF
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 8696 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 8696 at risk

Adverse event: Vision,NOS
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Dyspepsia/heartburn
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Melena/ GI bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Rectal bleeding/hematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Constitutional symptoms-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Reportable adverse event, NOS
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 8696 at risk

Adverse event: Respiratory infect w/o neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8696 at risk

Adverse event: Surgery-hemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 8696 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8696 at risk

Adverse event: Myalgia/arthralgia, NOS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Second primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 8696 at risk

Adverse event: CNS hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 8696 at risk

Adverse event: Cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 8696 at risk

Adverse event: Cranial nerve disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Neuro-other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 8696 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 8696 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 8696 at risk

Adverse event: Cardiac ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 529 affected / 8696 at risk

Adverse event: Breath odour
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 447 affected / 8696 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 632 affected / 8696 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 554 affected / 8696 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1072 affected / 8696 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 8737 at risk

Adverse event: Cardiovascular-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 8737 at risk

Adverse event: LVEF decrease/CHF
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 8737 at risk

Adverse event: Supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8737 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 8737 at risk

Adverse event: Eye-other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 8737 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8737 at risk

Adverse event: Hemorrhage w/o 3-4 thrombocyt
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8737 at risk

Adverse event: Reportable adverse event, NOS
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 8737 at risk

Adverse event: Liver-clinical
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 8737 at risk

Adverse event: Respiratory infect w/o neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8737 at risk

Adverse event: Respiratory infection, unk ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8737 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8737 at risk

Adverse event: Second primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 8737 at risk

Adverse event: CNS hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 8737 at risk

Adverse event: Cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 8737 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8737 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8737 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8737 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8737 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 8737 at risk

Adverse event: Carotid stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 8737 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 8737 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 8737 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 8737 at risk

Adverse event: Cardiac ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 551 affected / 8737 at risk

Adverse event: Breath odour
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 517 affected / 8737 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 660 affected / 8737 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 627 affected / 8737 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1070 affected / 8737 at risk