Study: NCT00004124

Adverse event: Reportable adverse event, NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 469 at risk

Adverse event: Flu-like symptoms-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 469 at risk

Adverse event: Second primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 469 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 469 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 71 affected / 469 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 20 affected / 469 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 8 affected / 469 at risk

Adverse event: Neutropenia/granulocytopenia
Serious: no
Organ System: Investigations
Frequency: 13 affected / 469 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 469 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 50 affected / 469 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 58 affected / 469 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 268 affected / 469 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 9 affected / 469 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 139 affected / 469 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 186 affected / 469 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 469 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 93 affected / 469 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 469 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 469 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 469 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 59 affected / 469 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Endocrine disorders
Frequency: 140 affected / 469 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 440 affected / 469 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 469 at risk

Adverse event: Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 469 at risk

Adverse event: Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 469 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 469 at risk

Adverse event: GI-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 469 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 469 at risk

Adverse event: Stomatitis/pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 469 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 469 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 469 at risk

Adverse event: SGOT (AST) increase
Serious: no
Organ System: Investigations
Frequency: 43 affected / 469 at risk

Adverse event: SGPT (ALT) increase
Serious: no
Organ System: Investigations
Frequency: 24 affected / 469 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 61 affected / 469 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 469 at risk

Adverse event: Joint,muscle,bone-other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 469 at risk

Adverse event: Muscle weakness (not neuro)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 58 affected / 469 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 59 affected / 469 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 95 affected / 469 at risk

Adverse event: Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 469 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 93 affected / 469 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 59 affected / 469 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 469 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 57 affected / 469 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 469 at risk

Adverse event: Chest pain,not cardio or pleur
Serious: no
Organ System: General disorders
Frequency: 16 affected / 469 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 469 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 469 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 162 affected / 469 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 469 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 469 at risk

Adverse event: Creatinine increase
Serious: no
Organ System: Investigations
Frequency: 10 affected / 469 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 137 affected / 469 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 131 affected / 469 at risk

Adverse event: Urine color change
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 469 at risk

Adverse event: Erectile impotence
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 217 affected / 469 at risk

Adverse event: Libido loss
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 168 affected / 469 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 460 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 460 at risk

Adverse event: Flu-like symptoms-other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 460 at risk

Adverse event: Infection with 3-4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 460 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 460 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 460 at risk

Adverse event: Second primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 460 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 460 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 152 affected / 460 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 319 affected / 460 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 51 affected / 460 at risk

Adverse event: Neutropenia/granulocytopenia
Serious: no
Organ System: Investigations
Frequency: 240 affected / 460 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 36 affected / 460 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 65 affected / 460 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 51 affected / 460 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 365 affected / 460 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 24 affected / 460 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 133 affected / 460 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 153 affected / 460 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 30 affected / 460 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 133 affected / 460 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 460 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 59 affected / 460 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 460 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 73 affected / 460 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Endocrine disorders
Frequency: 100 affected / 460 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 422 affected / 460 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 460 at risk

Adverse event: Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 133 affected / 460 at risk

Adverse event: Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 87 affected / 460 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 460 at risk

Adverse event: GI-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 460 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 210 affected / 460 at risk

Adverse event: Stomatitis/pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 460 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 460 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 460 at risk

Adverse event: SGOT (AST) increase
Serious: no
Organ System: Investigations
Frequency: 51 affected / 460 at risk

Adverse event: SGPT (ALT) increase
Serious: no
Organ System: Investigations
Frequency: 33 affected / 460 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 102 affected / 460 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 460 at risk

Adverse event: Joint,muscle,bone-other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 460 at risk

Adverse event: Muscle weakness (not neuro)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 83 affected / 460 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 70 affected / 460 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 99 affected / 460 at risk

Adverse event: Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 78 affected / 460 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 105 affected / 460 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 72 affected / 460 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 460 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 77 affected / 460 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 460 at risk

Adverse event: Chest pain,not cardio or pleur
Serious: no
Organ System: General disorders
Frequency: 23 affected / 460 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 88 affected / 460 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 49 affected / 460 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 173 affected / 460 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 460 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 59 affected / 460 at risk

Adverse event: Creatinine increase
Serious: no
Organ System: Investigations
Frequency: 24 affected / 460 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 117 affected / 460 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 130 affected / 460 at risk

Adverse event: Urine color change
Serious: no
Organ System: Renal and urinary disorders
Frequency: 44 affected / 460 at risk

Adverse event: Erectile impotence
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 171 affected / 460 at risk

Adverse event: Libido loss
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 134 affected / 460 at risk