Study: NCT00831766

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Death - Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Death - Multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Mucositis/stomatitis - Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: AST, SGOT - high
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pain - Extremity, limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 23 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 23 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 23 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 23 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Enteritis (inflammation of the small bowel)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 23 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 23 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 23 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 23 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 23 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Skin (cellulitis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 23 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Abdomen NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Infection with unknown ANC - Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Platelets - low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 23 at risk

Adverse event: Hemoglobin - low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 23 at risk

Adverse event: Neutrophils/granulocytes - low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 23 at risk

Adverse event: Leukocytes (total WBC) - low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 10 affected / 23 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pain - Chest wall
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Pain - back
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Pain - Throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 23 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 23 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 23 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Pulmonary/Upper Respiratory - Other, respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 23 at risk

Adverse event: Lymphatics - Other, fluid retention
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: ALT, SGPT - high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 23 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 23 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 23 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 23 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 23 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 23 at risk

Adverse event: AST, SGOT - high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 23 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 23 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 23 at risk

Adverse event: Alkaline phosphatase - increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 23 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 23 at risk

Adverse event: Creatinine - high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 23 at risk

Adverse event: Mood alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 23 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 23 at risk

Adverse event: Petechiae/purpura (hrmorrhage/bldding into skin or mucosa)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 23 at risk

Adverse event: Hemorrhage, G I- Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 23 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 23 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 23 at risk

Adverse event: Supraventricular and nodal arrhythmia - Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 23 at risk

Adverse event: Supraventricular and nodal arrhythmia - Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Supraventricular and nodal arrhythmia - Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 23 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 23 at risk

Adverse event: Renal/Genitourinary - Other, acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 23 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 23 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 23 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 23 at risk

Adverse event: Renal/Genitourinary - Other, hematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 23 at risk

Adverse event: Renal/Genitourinary - Other, renal insufficiency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 23 at risk

Adverse event: Neutrophils/granulocytes - low
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Platelets - low
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Cardiac Arrhythmia - Other, atrial fibrilation with rapid ventricular response
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Supraventricular and nodal arrhythmai - atrial fibirillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 28 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - abdomen, NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 28 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophnils - Gallbladder (cholecystitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Renal/Genitourinary - Other, acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 28 at risk

Adverse event: Infection with Grade 3 or 4 Neutrophils - Urinary Tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 28 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 28 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 28 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 28 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 28 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 28 at risk

Adverse event: Gastrointestinal - Other, GERD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 28 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 28 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 28 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Enteritis (inflammation of the small bowel)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 28 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 28 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 28 at risk

Adverse event: Rash: erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 28 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 28 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 28 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 28 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Blood
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 28 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Skin (cellulitis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 28 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 28 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Abdomen NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Infection with unknown ANC - Skin (cellulitis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Anal/perianal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk

Adverse event: Infection with unknown ANC - Anal/perianal
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk

Adverse event: Infection with unknown ANC - Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk

Adverse event: Platelets - low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 28 at risk

Adverse event: Hemoglobin - low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 28 at risk

Adverse event: Neutrophils/granulocytes - low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 28 at risk

Adverse event: Leukocytes (total WBC) - low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 28 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 7 affected / 28 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 28 at risk

Adverse event: Pain - Chest wall
Serious: no
Organ System: General disorders
Frequency: 7 affected / 28 at risk

Adverse event: Pain - back
Serious: no
Organ System: General disorders
Frequency: 6 affected / 28 at risk

Adverse event: Pain - Throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 6 affected / 28 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: no
Organ System: General disorders
Frequency: 5 affected / 28 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Pain - Oral cavity
Serious: no
Organ System: General disorders
Frequency: 3 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 28 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 13 affected / 28 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 28 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 28 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 28 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 28 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 28 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 28 at risk

Adverse event: Pulmonary/Upper Respiratory - Other, respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 28 at risk

Adverse event: Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 28 at risk

Adverse event: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 28 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 28 at risk

Adverse event: Lymphatics - Other, fluid retention
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 28 at risk

Adverse event: ALT, SGPT - high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 28 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 28 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 28 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 28 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 28 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 28 at risk

Adverse event: AST, SGOT - high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 28 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 28 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Alkaline phosphatase - increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 28 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 28 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 28 at risk

Adverse event: Mood alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 28 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 28 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 28 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Mental status - Change
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 28 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 28 at risk

Adverse event: Petechiae/purpura (hrmorrhage/bldding into skin or mucosa)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 28 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 28 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 28 at risk

Adverse event: Ventricular arrhythmia - Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 28 at risk

Adverse event: Supraventricular and nodal arrhythmia - Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 28 at risk

Adverse event: Supraventricular and nodal arrhythmia - Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 28 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 28 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 28 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 28 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 28 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 28 at risk

Adverse event: Renal/Genitourinary - Other, renal insufficiency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: Infection with unknown ANC - Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 28 at risk