Study: NCT00436852

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: " Bronchospasm, wheezing"
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Death not associated with CTCAE term - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hemorrhage, GI - Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Infection (clinical or microbiological Dx) w/ Gr 3-4 neutrophils, ANC<1.0x10e9 - Paranasal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Infection with unknown ANC - Middle ear (otitis media)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Mood alteration - Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain - Bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain - Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 44 at risk

Adverse event: Personality/behavioral
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 44 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 44 at risk

Adverse event: "ALT, SGPT (serum glutamic pyruvic transaminase)"
Serious: no
Organ System: Investigations
Frequency: 9 affected / 44 at risk

Adverse event: "AST: AST, SGOT(serum glutamic oxaloacetic transaminase)"
Serious: no
Organ System: Investigations
Frequency: 7 affected / 44 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 44 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 44 at risk

Adverse event: " Fatigue (asthenia, lethargy, malaise)"
Serious: no
Organ System: General disorders
Frequency: 13 affected / 44 at risk

Adverse event: " Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)"
Serious: no
Organ System: General disorders
Frequency: 6 affected / 44 at risk

Adverse event: GGT: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 44 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 44 at risk

Adverse event: "Hyperglycemia: Glucose, serum-high (hyperglycemia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 44 at risk

Adverse event: "Hypokalemia: Potassium, serum-low (hypokalemia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 44 at risk

Adverse event: "Hypomagnesemia: Magnesium, serum-low (hypomagnesemia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 44 at risk

Adverse event: "Hyponatremia: Sodium, serum-low (hyponatremia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 44 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 17 affected / 44 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 44 at risk

Adverse event: Mood alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 44 at risk

Adverse event: Mood alteration - Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 44 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 44 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 17 affected / 44 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 44 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 44 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 44 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 44 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 44 at risk

Adverse event: Pain - Stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Pain - Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 13 affected / 44 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 44 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 44 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 47 at risk

Adverse event: Death not associated with CTCAE term - Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Febrile neutropenia (fever, unk. origin,w/o infection,ANC<1x10e9, fever>=38.5C)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 47 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Gait/walking: Extremity-lower (gait/walking)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 47 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hypoglycemia: Glucose, serum-low (hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hypokalemia: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 47 at risk

Adverse event: Hyponatremia: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Infection (clinical or microbiological Dx) w/ Gr 3-4 neutrophils, ANC<1.0x10e9 - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Bone (osteomyelitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Infection with unknown ANC - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 47 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Mood alteration - Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 47 at risk

Adverse event: Mood alteration - Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 47 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 47 at risk

Adverse event: Obstruction, GI - Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 47 at risk

Adverse event: Pain - Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 47 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pain - Muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pain - Neuralgia/peripheral nerve
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 47 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 47 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 47 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 47 at risk

Adverse event: "ALT, SGPT (serum glutamic pyruvic transaminase)"
Serious: no
Organ System: Investigations
Frequency: 14 affected / 47 at risk

Adverse event: "AST: AST, SGOT(serum glutamic oxaloacetic transaminase)"
Serious: no
Organ System: Investigations
Frequency: 14 affected / 47 at risk

Adverse event: "Albumin, serum-low (hypoalbuminemia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 47 at risk

Adverse event: "Bicarbonate, serum-low"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 47 at risk

Adverse event: " Cholesterol: Cholesterol, serum-high (hypercholestremia)"
Serious: no
Organ System: Investigations
Frequency: 3 affected / 47 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 4 affected / 47 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 47 at risk

Adverse event: " Fatigue (asthenia, lethargy, malaise)"
Serious: no
Organ System: General disorders
Frequency: 9 affected / 47 at risk

Adverse event: " Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)"
Serious: no
Organ System: General disorders
Frequency: 12 affected / 47 at risk

Adverse event: GGT: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 47 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 47 at risk

Adverse event: " Hemorrhage, pulmonary/upper respiratory - Nose"
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: "Hypercalcemia: Calcium, serum-high (hypercalcemia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 47 at risk

Adverse event: "Hyperglycemia: Glucose, serum-high (hyperglycemia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 47 at risk

Adverse event: "Hypermagnesemia: Magnesium, serum-high (hypermagnesemia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 47 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 47 at risk

Adverse event: "Hypertriglyceridemia: Triglyceride, serum-high (hypertriglyceridemia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 47 at risk

Adverse event: "Hypocalcemia: Calcium, serum-low (hypocalcemia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 47 at risk

Adverse event: "Hypoglycemia: Glucose, serum-low (hypoglycemia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 47 at risk

Adverse event: "Hypokalemia: Potassium, serum-low (hypokalemia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 47 at risk

Adverse event: "Hypomagnesemia: Magnesium, serum-low (hypomagnesemia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 47 at risk

Adverse event: "Hyponatremia: Sodium, serum-low (hyponatremia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 47 at risk

Adverse event: "Hypophosphatemia: Phosphate, serum-low (hypophosphatemia)"
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 47 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 47 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 19 affected / 47 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 10 affected / 47 at risk

Adverse event: Mood alteration - Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 47 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 47 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 14 affected / 47 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 47 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 47 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 47 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 47 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 47 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 47 at risk

Adverse event: Pain - Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 18 affected / 47 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 47 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 47 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 47 at risk