Study: NCT00022659

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Hematologic Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Thrombosis Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 62 at risk

Adverse event: Ischemia/Cardiac Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Partial Thromboplastin Time
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 62 at risk

Adverse event: Weight Gain(No Vod)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Flushing
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Gi Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Melena/Gi Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 62 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Pain Tumor
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Voice Changes/Stridor/Larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Frequency: 8 affected / 62 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 62 at risk

Adverse event: Inner Ear/Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 62 at risk

Adverse event: Middle Ear/Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 62 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 62 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 62 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 62 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 62 at risk

Adverse event: Transfusion Prbc's
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 62 at risk

Adverse event: Hematologic Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Conduction Abnorm Atrioventricular Block
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 62 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 62 at risk

Adverse event: Arrhythmia Super Ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Phlebitis superficial
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 62 at risk

Adverse event: Thrombosis Embolism
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 62 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 62 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Ischemia/Cardiac Infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Prothrombin time
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 62 at risk

Adverse event: Coagulation Other
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 62 at risk

Adverse event: Partial Thromboplastin Time
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 62 at risk

Adverse event: Fever(No Neutropenia)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 62 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 8 affected / 62 at risk

Adverse event: Rigors Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: Weight Gain(No Vod)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 40 affected / 62 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 62 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 62 at risk

Adverse event: Rash Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 62 at risk

Adverse event: Skin Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 62 at risk

Adverse event: Pigmentation Changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Hand-Foot Skin Reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 62 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 62 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 62 at risk

Adverse event: Hot Flashes/Flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 62 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 62 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 62 at risk

Adverse event: Diarrhea With Colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Mouth Dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 62 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 62 at risk

Adverse event: Ascites Non-Malignant
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Dyspepsia/Heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 62 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Dysphagia Esophagitis Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 62 at risk

Adverse event: Diarrhea Without Colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 62 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 62 at risk

Adverse event: Stomatitis/Pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 62 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 62 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 62 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 62 at risk

Adverse event: Gi Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 62 at risk

Adverse event: Hemorrhage Other
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 62 at risk

Adverse event: Rectal Bleeding/Hematochezia
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 62 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 62 at risk

Adverse event: Melena/Gi Bleeding
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 62 at risk

Adverse event: Hemorrhage Without Grade 3/4 Thrombocytopenia
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 62 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 62 at risk

Adverse event: Hematuria No Vaginal Bleeding
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 62 at risk

Adverse event: Ggt(Gamma-Glutamyltranspeptidase)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Hepatic Other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 62 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 62 at risk

Adverse event: Sgot(Alt)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 62 at risk

Adverse event: Sgot(Ast)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 19 affected / 62 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 62 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 62 at risk

Adverse event: Infection Without Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 62 at risk

Adverse event: Lymphatics Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Alkalosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 62 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 62 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 62 at risk

Adverse event: Metabolic Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 62 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 62 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 62 at risk

Adverse event: Hypertyiglyceridemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 62 at risk

Adverse event: Blood bicarbonate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 62 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 62 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 62 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 62 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 62 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 62 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 62 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 62 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 62 at risk

Adverse event: Hypomagnesmia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 62 at risk

Adverse event: Musculoskeletal Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 62 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 62 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 62 at risk

Adverse event: Extrapyramidal
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Mood Alteration Anxeity/Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 62 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 62 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 62 at risk

Adverse event: Mood Alteration Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 62 at risk

Adverse event: Neuropathy Sensor
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 62 at risk

Adverse event: Pyramidal Tract Dysfunction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 62 at risk

Adverse event: Ocular Other
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 62 at risk

Adverse event: Tearing
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 62 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 62 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 62 at risk

Adverse event: Vision Blurres
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 62 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 29 affected / 62 at risk

Adverse event: Pain Other
Serious: no
Organ System: General disorders
Frequency: 14 affected / 62 at risk

Adverse event: Pain Tumor
Serious: no
Organ System: General disorders
Frequency: 5 affected / 62 at risk

Adverse event: Pleuritic pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Neuralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Ear pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 19 affected / 62 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 62 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 62 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 62 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 62 at risk

Adverse event: Pain Rectal/Perirectal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Voice Changes/Stridor/Larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 62 at risk

Adverse event: Pulmonary Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 62 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Pneumonitis/Pulmonary Infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 62 at risk

Adverse event: Urinary Frequency/Urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 62 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 62 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 62 at risk

Adverse event: Renal/Gu Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 62 at risk

Adverse event: Vaginitis No Infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 62 at risk

Adverse event: Ureteral Obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Bladder Spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 62 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 62 at risk

Adverse event: Libido
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 62 at risk