Study: NCT00006237

Adverse event: Reportable adverse event, NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 193 at risk

Adverse event: Cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 193 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 193 at risk

Adverse event: Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 193 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 193 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 193 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 79 affected / 193 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 193 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 27 affected / 193 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 30 affected / 193 at risk

Adverse event: Neutropenia/granulocytopenia
Serious: no
Organ System: Investigations
Frequency: 38 affected / 193 at risk

Adverse event: SGOT (AST) increase
Serious: no
Organ System: Investigations
Frequency: 42 affected / 193 at risk

Adverse event: SGPT (ALT) increase
Serious: no
Organ System: Investigations
Frequency: 53 affected / 193 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 15 affected / 193 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 193 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 193 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 193 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 193 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 193 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 193 at risk

Adverse event: Platelet transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 185 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Respiratory infect w/ neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 185 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 185 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 67 affected / 185 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 185 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 27 affected / 185 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 24 affected / 185 at risk

Adverse event: Alkaline phosphatase increase
Serious: no
Organ System: Investigations
Frequency: 16 affected / 185 at risk

Adverse event: Creatinine increase
Serious: no
Organ System: Investigations
Frequency: 13 affected / 185 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 42 affected / 185 at risk

Adverse event: Neutropenia/granulocytopenia
Serious: no
Organ System: Investigations
Frequency: 65 affected / 185 at risk

Adverse event: SGOT (AST) increase
Serious: no
Organ System: Investigations
Frequency: 20 affected / 185 at risk

Adverse event: SGPT (ALT) increase
Serious: no
Organ System: Investigations
Frequency: 20 affected / 185 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 58 affected / 185 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 185 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 185 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 185 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 185 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 185 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 185 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 185 at risk