Study: NCT00003641

Adverse event: INNER EAR/HEARING
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 439 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 439 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 439 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 439 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 439 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 439 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 439 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 439 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 439 at risk

Adverse event: Neutrophils decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 439 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 439 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 439 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 439 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 439 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 439 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 439 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 439 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 439 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 439 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 439 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 439 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 439 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 439 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 439 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 439 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 439 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 17 affected / 439 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 568 at risk

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 38 affected / 568 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 130 affected / 568 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 568 at risk

Adverse event: Hematologic-other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 568 at risk

Adverse event: Supraventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 568 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 568 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 568 at risk

Adverse event: Cardiac-left ventric
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 568 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 568 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 568 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 568 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 568 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 70 affected / 568 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 568 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 568 at risk

Adverse event: CONSTITUTIONAL
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 568 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 568 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 568 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 568 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 568 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 568 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 568 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 568 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 568 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 568 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 568 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 568 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 568 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 74 affected / 568 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 30 affected / 568 at risk

Adverse event: Catheter-related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 568 at risk

Adverse event: Infection w/ grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 568 at risk

Adverse event: INFECTION W/ UNKNOWN ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 568 at risk

Adverse event: Infection w/o neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 568 at risk

Adverse event: INFECTION-OTHER
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 568 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 568 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 568 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 568 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 568 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 568 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 568 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 568 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 568 at risk

Adverse event: Dizziness/lightheadedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 568 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 568 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 568 at risk

Adverse event: Anxiety/agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 568 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 11 affected / 568 at risk

Adverse event: Neuropathy-cranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 568 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 568 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 568 at risk

Adverse event: Speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 568 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 568 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 568 at risk

Adverse event: Neurologic-other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 568 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 568 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 568 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 568 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 568 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 42 affected / 568 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 568 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 568 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 568 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 568 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 568 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 568 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 568 at risk

Adverse event: URINARY FREQUENCY/URGENCY
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 568 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 123 affected / 568 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Investigations
Frequency: 321 affected / 568 at risk

Adverse event: Neutrophils decreased
Serious: no
Organ System: Investigations
Frequency: 283 affected / 568 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 200 affected / 568 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 454 affected / 568 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 256 affected / 568 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 342 affected / 568 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 83 affected / 568 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 120 affected / 568 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 568 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 64 affected / 568 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 283 affected / 568 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 106 affected / 568 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 340 affected / 568 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 176 affected / 568 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 133 affected / 568 at risk

Adverse event: GI-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 568 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 69 affected / 568 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 43 affected / 568 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 373 affected / 568 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 80 affected / 568 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 95 affected / 568 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 113 affected / 568 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 91 affected / 568 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 90 affected / 568 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 568 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 137 affected / 568 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 270 affected / 568 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 229 affected / 568 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 33 affected / 568 at risk