Study: NCT00066573

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 3761 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3761 at risk

Adverse event: Restrictive cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3761 at risk

Adverse event: Supraven.arrhyth. Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3761 at risk

Adverse event: Ventric.arrhyth. Trigeminy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3761 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3761 at risk

Adverse event: Ocular - Other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3761 at risk

Adverse event: Retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3761 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3761 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3761 at risk

Adverse event: Blood bilirubin
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3761 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3761 at risk

Adverse event: cTnI
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3761 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3761 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3761 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3761 at risk

Adverse event: Neuropathy: cranial CN VIII
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3761 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3761 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3761 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 3761 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 614 affected / 3761 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 464 affected / 3761 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 399 affected / 3761 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 574 affected / 3761 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 436 affected / 3761 at risk

Adverse event: Pain Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 202 affected / 3761 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 749 affected / 3761 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1697 affected / 3761 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 290 affected / 3761 at risk

Adverse event: Blood cholesterol
Serious: no
Organ System: Investigations
Frequency: 591 affected / 3761 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 257 affected / 3761 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 229 affected / 3761 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 238 affected / 3761 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 347 affected / 3761 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 264 affected / 3761 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1243 affected / 3761 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 480 affected / 3761 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 381 affected / 3761 at risk

Adverse event: Pain Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 468 affected / 3761 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2085 affected / 3761 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 667 affected / 3761 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 526 affected / 3761 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 576 affected / 3761 at risk

Adverse event: Pain Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 414 affected / 3761 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 574 affected / 3761 at risk

Adverse event: Mood alteration Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 258 affected / 3761 at risk

Adverse event: Mood alteration Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 374 affected / 3761 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 288 affected / 3761 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 248 affected / 3761 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 671 affected / 3761 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 656 affected / 3761 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 235 affected / 3761 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 474 affected / 3761 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 626 affected / 3761 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 2086 affected / 3761 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 300 affected / 3761 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3759 at risk

Adverse event: Night blindness
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3759 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3759 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3759 at risk

Adverse event: Speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3759 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3759 at risk

Adverse event: Incontinence, urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3759 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3759 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 606 affected / 3759 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 414 affected / 3759 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 363 affected / 3759 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 556 affected / 3759 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 442 affected / 3759 at risk

Adverse event: Pain Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 220 affected / 3759 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 760 affected / 3759 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1749 affected / 3759 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 292 affected / 3759 at risk

Adverse event: Blood cholesterol
Serious: no
Organ System: Investigations
Frequency: 677 affected / 3759 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 286 affected / 3759 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 218 affected / 3759 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 249 affected / 3759 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 373 affected / 3759 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 242 affected / 3759 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1369 affected / 3759 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 504 affected / 3759 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 410 affected / 3759 at risk

Adverse event: Pain Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 511 affected / 3759 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2086 affected / 3759 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 629 affected / 3759 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 504 affected / 3759 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 528 affected / 3759 at risk

Adverse event: Pain Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 399 affected / 3759 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 521 affected / 3759 at risk

Adverse event: Mood alteration Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 229 affected / 3759 at risk

Adverse event: Mood alteration Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 377 affected / 3759 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 312 affected / 3759 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 260 affected / 3759 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 666 affected / 3759 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 652 affected / 3759 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 212 affected / 3759 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 437 affected / 3759 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 603 affected / 3759 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 2138 affected / 3759 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 326 affected / 3759 at risk