Study: NCT00083174

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Supraven.arrhyth. Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2240 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Cardiac General - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2240 at risk

Adverse event: Endocrine - Other
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2240 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Incontinence, anal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Obstruction, GI Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2240 at risk

Adverse event: GI - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 2240 at risk

Adverse event: Infec.w.norm.ANC Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2240 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2240 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Gamma-glutamyltransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 2240 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 2240 at risk

Adverse event: Musculoskeletal - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2240 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 2240 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Ocular - Other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Pain Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2240 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2240 at risk

Adverse event: Secondary Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2240 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 341 affected / 2240 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 900 affected / 2240 at risk

Adverse event: Fatigue
Serious: no
Organ System: Endocrine disorders
Frequency: 525 affected / 2240 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Endocrine disorders
Frequency: 486 affected / 2240 at risk

Adverse event: Insomnia
Serious: no
Organ System: Endocrine disorders
Frequency: 230 affected / 2240 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 118 affected / 2240 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 332 affected / 2240 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 155 affected / 2240 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 247 affected / 2240 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 189 affected / 2240 at risk

Adverse event: mood alteration or depression
Serious: no
Organ System: Nervous system disorders
Frequency: 236 affected / 2240 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 306 affected / 2240 at risk

Adverse event: pain extremity
Serious: no
Organ System: General disorders
Frequency: 153 affected / 2240 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 665 affected / 2240 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 147 affected / 2240 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 234 affected / 2240 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 352 affected / 2240 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2248 at risk

Adverse event: Cardiac General - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2248 at risk

Adverse event: GI - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Infection (doc.clin.) Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2248 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2248 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 2248 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Musculoskeletal - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2248 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 2248 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Syndromes - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2248 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2248 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 354 affected / 2248 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 718 affected / 2248 at risk

Adverse event: Fatigue
Serious: no
Organ System: Endocrine disorders
Frequency: 465 affected / 2248 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Endocrine disorders
Frequency: 433 affected / 2248 at risk

Adverse event: Insomnia
Serious: no
Organ System: Endocrine disorders
Frequency: 189 affected / 2248 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 75 affected / 2248 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 289 affected / 2248 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 122 affected / 2248 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 196 affected / 2248 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 209 affected / 2248 at risk

Adverse event: mood alteration or depression
Serious: no
Organ System: Nervous system disorders
Frequency: 235 affected / 2248 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 222 affected / 2248 at risk

Adverse event: pain extremity
Serious: no
Organ System: General disorders
Frequency: 122 affected / 2248 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 606 affected / 2248 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 192 affected / 2248 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 266 affected / 2248 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 343 affected / 2248 at risk