Study: NCT00002651

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 732 at risk

Adverse event: Cardiovascular-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 732 at risk

Adverse event: LVEF decrease/CHF
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 732 at risk

Adverse event: Flu-like symptoms-other
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 732 at risk

Adverse event: Second primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 732 at risk

Adverse event: Cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 732 at risk

Adverse event: Pleural effusions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 732 at risk

Adverse event: Hemorrhage-other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 732 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 732 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 86 affected / 732 at risk

Adverse event: Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 81 affected / 732 at risk

Adverse event: Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 93 affected / 732 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 732 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 381 affected / 732 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 140 affected / 732 at risk

Adverse event: Alkaline phosphatase increase
Serious: no
Organ System: Investigations
Frequency: 58 affected / 732 at risk

Adverse event: Creatinine increase
Serious: no
Organ System: Investigations
Frequency: 107 affected / 732 at risk

Adverse event: SGOT (AST) increase
Serious: no
Organ System: Investigations
Frequency: 49 affected / 732 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 60 affected / 732 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 85 affected / 732 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 92 affected / 732 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 239 affected / 732 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 732 at risk

Adverse event: Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 732 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 111 affected / 732 at risk

Adverse event: Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 75 affected / 732 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 41 affected / 732 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 107 affected / 732 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 141 affected / 732 at risk

Adverse event: Libido loss
Serious: no
Organ System: Psychiatric disorders
Frequency: 262 affected / 732 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 141 affected / 732 at risk

Adverse event: Erectile impotence
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 304 affected / 732 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 181 affected / 732 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 52 affected / 732 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 109 affected / 732 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 81 affected / 732 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 245 affected / 732 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 511 affected / 732 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 37 affected / 732 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 702 at risk

Adverse event: Cardiovascular-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 702 at risk

Adverse event: LVEF decrease/CHF
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 702 at risk

Adverse event: Flu-like symptoms-other
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 702 at risk

Adverse event: Cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 702 at risk

Adverse event: Lung-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 702 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 85 affected / 702 at risk

Adverse event: Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 702 at risk

Adverse event: Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 79 affected / 702 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 702 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 364 affected / 702 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 131 affected / 702 at risk

Adverse event: Alkaline phosphatase increase
Serious: no
Organ System: Investigations
Frequency: 95 affected / 702 at risk

Adverse event: Creatinine increase
Serious: no
Organ System: Investigations
Frequency: 87 affected / 702 at risk

Adverse event: SGOT (AST) increase
Serious: no
Organ System: Investigations
Frequency: 70 affected / 702 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 33 affected / 702 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 91 affected / 702 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 63 affected / 702 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 272 affected / 702 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 702 at risk

Adverse event: Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 702 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 95 affected / 702 at risk

Adverse event: Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 61 affected / 702 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 41 affected / 702 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 96 affected / 702 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 123 affected / 702 at risk

Adverse event: Libido loss
Serious: no
Organ System: Psychiatric disorders
Frequency: 226 affected / 702 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 147 affected / 702 at risk

Adverse event: Erectile impotence
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 256 affected / 702 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 158 affected / 702 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 702 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 116 affected / 702 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 65 affected / 702 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 176 affected / 702 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 440 affected / 702 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 36 affected / 702 at risk