Study: NCT00008138

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 58 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 58 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 58 at risk

Adverse event: PRBC transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 58 at risk

Adverse event: Platelet transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 58 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 58 at risk

Adverse event: Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 58 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 58 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 58 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 58 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 58 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 17 affected / 58 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 58 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 58 at risk

Adverse event: Infection w/o 3-4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 58 at risk

Adverse event: Urinary tr infect w/o neutrop
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 58 at risk

Adverse event: Surgery-hemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 58 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 9 affected / 58 at risk

Adverse event: Neutropenia/granulocytopenia
Serious: no
Organ System: Investigations
Frequency: 13 affected / 58 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 58 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 58 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 58 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 58 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 58 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 58 at risk

Adverse event: Muscle weakness (not neuro)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 58 at risk

Adverse event: Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 58 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 58 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 58 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 58 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 26 at risk

Adverse event: PRBC transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 26 at risk

Adverse event: Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 26 at risk

Adverse event: Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 26 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 15 affected / 26 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Respiratory infect w/o neutrop
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 26 at risk

Adverse event: Urinary tr infect w/ neutrop
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Device related infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 26 at risk

Adverse event: Local injection site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 26 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 17 affected / 26 at risk

Adverse event: Neutropenia/granulocytopenia
Serious: no
Organ System: Investigations
Frequency: 15 affected / 26 at risk

Adverse event: SGOT (AST) increase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 26 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 26 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 26 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 26 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 26 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 26 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 26 at risk

Adverse event: Muscle weakness (not neuro)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 26 at risk

Adverse event: Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 26 at risk

Adverse event: Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 26 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 26 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 26 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 26 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 26 at risk