Study: NCT00088413

Adverse event: BLOOD/BONE MARROW:: Hemoglobin*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Leukocytes (total WBC)*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Lymphopenia*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Platelets*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Anorexia*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Constipation*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Dehydration*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Diarrhea*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Distension/bloating, abdominal*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Dysphagia (difficulty swallowing)*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Heartburn/dyspepsia*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Nausea*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Vomiting*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: LYMPHATICS:: Edema: limb*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: SYNDROMES:: Flu-like syndrome*3
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)*3
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 25 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Palpitations*3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: CARDIAC GENERAL:: Hypotension*3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: COAGULATION:: INR (International Normalized Ratio of prothrombin time)*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: COAGULATION:: PTT (Partial Thromboplastin Time)*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Constitutional Symptoms - Other (Cold )*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fatigue (asthenia, lethargy, malaise)*3
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia,
Serious: yes
Organ System: General disorders
Notes: where neutropenia is defined as ANC \<1.0 x 10e9/L)\*3
Frequency: 10 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Insomnia*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Rigors/chills*3
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)*3
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Weight loss*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: DEATH:: Death not associated with CTCAE term:: Disease progression NOS*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Bruising (in absence of Grade 3 or 4 thrombocytopenia)*3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Induration/fibrosis (skin and subcutaneous tissue)*3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes*3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Nail changes*3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Pruritus/itching*3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Rash/desquamation*3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: ENDOCRINE:: Hot flashes/flushes*3
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 25 at risk

Adverse event: ENDOCRINE:: Thyroid function, low (hypothyroidism)*3
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Flatulence*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Oral cavity*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Obstruction, GI:: Small bowel NOS*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Taste alteration (dysgeusia)*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Lower GI NOS*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Rectum*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Bladder*3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Nose*3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEPATOBILIARY/PANCREAS:: Pancreatitis*3
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 25 at risk

Adverse event: INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Sinus*3
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Urinary tract NOS*3
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: INFECTION:: Infection with unknown ANC:: Urinary tract NOS*3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: INFECTION:: Infection with unknown ANC:: Wound*3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: LYMPHATICS:: Lymphatics - Other (Edema-Left ankle)*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: ALT, SGPT (serum glutamic pyruvic transaminase)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: AST, SGOT(serum glutamic oxaloacetic transaminase)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Alkaline phosphatase*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Amylase*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Bicarbonate, serum-low*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Bilirubin (hyperbilirubinemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: CPK (creatine phosphokinase)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Calcium, serum-high (hypercalcemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Calcium, serum-low (hypocalcemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Cholesterol, serum-high (hypercholesteremia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Creatinine*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: GGT (gamma-Glutamyl transpeptidase)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Glucose, serum-high (hyperglycemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Lipase*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Magnesium, serum-high (hypermagnesemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Magnesium, serum-low (hypomagnesemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Phosphate, serum-low (hypophosphatemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Potassium, serum-high (hyperkalemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Potassium, serum-low (hypokalemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Proteinuria*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Sodium, serum-low (hyponatremia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Uric acid, serum-high (hyperuricemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 25 at risk

Adverse event: NEUROLOGY:: Dizziness*3
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 25 at risk

Adverse event: NEUROLOGY:: Mood alteration:: Anxiety*3
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: NEUROLOGY:: Mood alteration:: Depression*3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: NEUROLOGY:: Neuropathy: cranial:: CN I Smell*3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: NEUROLOGY:: Neuropathy: cranial:: CN VIII Hearing and balance*3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: NEUROLOGY:: Syncope (fainting)*3
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: OCULAR/VISUAL:: Keratitis (corneal inflammation/corneal ulceration)*3
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: OCULAR/VISUAL:: Vision-blurred vision*3
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Abdomen NOS*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: PAIN:: Pain:: Back*3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 25 at risk

Adverse event: PAIN:: Pain:: Bladder*3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Bone*3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: PAIN:: Pain:: Chest wall*3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Extremity-limb*3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 25 at risk

Adverse event: PAIN:: Pain:: Eye*3
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Head/headache*3
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 25 at risk

Adverse event: PAIN:: Pain:: Joint*3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 25 at risk

Adverse event: PAIN:: Pain:: Muscle*3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 25 at risk

Adverse event: PAIN:: Pain:: Neck*3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Oral cavity*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Pain NOS*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Stomach*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Bronchospasm, wheezing*3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Cough*3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Dyspnea (shortness of breath)*3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: RENAL/GENITOURINARY:: Bladder spasms*3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: RENAL/GENITOURINARY:: Renal/Genitourinary - Other (Dysuria)*3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: RENAL/GENITOURINARY:: Urinary frequency/urgency*3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal - Other (Emesis)*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain - Other (Pain-Upper right quadrant)*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain - Other (Rt. flank)*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain - Other (Rt. ear)*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain - Other (Pain from inserted biliary stents)*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)*3
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Hemoglobin*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Leukocytes (total WBC)*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Lymphopenia*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Platelets*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fatigue (asthenia, lethargy, malaise)*3
Serious: no
Organ System: General disorders
Frequency: 13 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Insomnia*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Rigors/chills*3
Serious: no
Organ System: General disorders
Frequency: 12 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)*3
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes*3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Pruritus/itching*3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Rash/desquamation*3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Anorexia*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Constipation*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Diarrhea*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Distension/bloating, abdominal*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Dysphagia (difficulty swallowing)*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Heartburn/dyspepsia*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Nausea*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Vomiting*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Urinary tract NOS*3
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: LYMPHATICS:: Edema: limb*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: ALT, SGPT (serum glutamic pyruvic transaminase)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: AST, SGOT(serum glutamic oxaloacetic transaminase)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Alkaline phosphatase*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Bilirubin (hyperbilirubinemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: CPK (creatine phosphokinase)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Calcium, serum-high (hypercalcemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Calcium, serum-low (hypocalcemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Cholesterol, serum-high (hypercholesteremia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Glucose, serum-high (hyperglycemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Magnesium, serum-high (hypermagnesemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Magnesium, serum-low (hypomagnesemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Phosphate, serum-low (hypophosphatemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Potassium, serum-high (hyperkalemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Potassium, serum-low (hypokalemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Proteinuria*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Sodium, serum-low (hyponatremia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Uric acid, serum-high (hyperuricemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 25 at risk

Adverse event: NEUROLOGY:: Dizziness*3
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 25 at risk

Adverse event: NEUROLOGY:: Mood alteration:: Depression*3
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Abdomen NOS*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: PAIN:: Pain:: Back*3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 25 at risk

Adverse event: PAIN:: Pain:: Bone*3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: PAIN:: Pain:: Chest wall*3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Extremity-limb*3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 25 at risk

Adverse event: PAIN:: Pain:: Eye*3
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Head/headache*3
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 25 at risk

Adverse event: PAIN:: Pain:: Muscle*3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 25 at risk

Adverse event: PAIN:: Pain:: Stomach*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Cough*3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Dyspnea (shortness of breath)*3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: RENAL/GENITOURINARY:: Urinary frequency/urgency*3
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: SYNDROMES:: Flu-like syndrome*3
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Palpitations*3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: CARDIAC GENERAL:: Hypotension*3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: COAGULATION:: INR (International Normalized Ratio of prothrombin time)*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: COAGULATION:: PTT (Partial Thromboplastin Time)*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Constitutional Symptoms - Other (Cold)*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia, where neutropenia is defined as ANC
Serious: no
Organ System: General disorders
Notes: \<1.0 x 10e9/L)\*3
Frequency: 10 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Weight loss*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Bruising (in absence of Grade 3 or 4 thrombocytopenia)*3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Induration/fibrosis (skin and subcutaneous tissue)*3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Nail changes*3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: ENDOCRINE:: Hot flashes/flushes*3
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 25 at risk

Adverse event: ENDOCRINE:: Thyroid function, low (hypothyroidism)*3
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Dehydration*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Flatulence*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Oral cavity*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Obstruction, GI:: Small bowel NOS*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Taste alteration (dysgeusia)*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Lower GI NOS*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Rectum*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Bladder*3
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Nose*3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Sinus*3
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: INFECTION:: Infection with unknown ANC:: Urinary tract NOS*3
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: LYMPHATICS:: Lymphatics - Other (Edema-left ankle)*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Amylase*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Bicarbonate, serum-low*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Creatinine*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: GGT (gamma-Glutamyl transpeptidase)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Lipase*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: NEUROLOGY:: Mood alteration:: Anxiety*3
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: NEUROLOGY:: Neuropathy: cranial:: CN I Smell*3
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: NEUROLOGY:: Neuropathy: cranial:: CN VIII Hearing and balance*3
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: NEUROLOGY:: Syncope (fainting)*3
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: OCULAR/VISUAL:: Keratitis (corneal inflammation/corneal ulceration)*3
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: OCULAR/VISUAL:: Vision-blurred vision*3
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain - Other (Pain-upper right quadrant)*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Bladder*3
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Joint*3
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: PAIN:: Pain:: Neck*3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Oral cavity*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain:: Pain NOS*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Bronchospasm, wheezing*3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: RENAL/GENITOURINARY:: Bladder spasms*3
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: RENAL/GENITOURINARY:: Renal/Genitourinary - Other (Dysuria)*3
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal - Other (Emesis)*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain - Other (Rt. flank)*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain - Other (Rt. ear)*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pain - Other (Pain from inserted biliary stents)*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Activated partial thromboplastin time prolonged*4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Alanine aminotransferase increased*4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Alkaline phosphatase increased*4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Allergic reaction*4
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Allergic rhinitis*4
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Anemia*4
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Aspartate aminotransferase increased*4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: BLOOD/BONE MARROW:: Hemoglobin*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 26 at risk

Adverse event: BLOOD/BONE MARROW:: Leukocytes (total WBC)*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: BLOOD/BONE MARROW:: Lymphopenia*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: BLOOD/BONE MARROW:: Platelets*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Back pain*4
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Bruising*4
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 26 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus tachycardia*3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Weight gain*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: CPK increased*4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Creatinine increased*4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Cystitis noninfective*4
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: DERMATOLOGY/SKIN:: Dermatology/Skin - Other (Allergic reaction-Tape)*3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: DERMATOLOGY/SKIN:: Dry skin*3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes*3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 26 at risk

Adverse event: Delirium*4
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Depression*4
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhea*4
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Fall*4
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 26 at risk

Adverse event: Fever*4
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Anorexia*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Constipation*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Dehydration*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Diarrhea*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Distension/bloating, abdominal*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Dysphagia (difficulty swallowing)*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Heartburn/dyspepsia*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Nausea*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Vomiting*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Gingival pain*4
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Urinary NOS*3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage/Bleeding - Other (Spotting)*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hallucinations*4
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Headache*4
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hyperglycemia*4
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypernatremia*4
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hyperuricemia*4
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypoalbuminemia*4
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypocalcemia*4
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypoglycemia*4
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypokalemia*4
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypomagnesemia*4
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hyponatremia*4
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypophosphatemia*4
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: INFECTION:: Infection - Other (Lt. lower leg, redness, swelling, & whelts)*3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Lung (pneumonia)*3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Injection site reaction*4
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Investigations - Other, specify*4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: LYMPHATICS:: Edema: limb*3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Lipase increased*4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Lymphocyte count decreased*4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Glucose, serum-low (hypoglycemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Hemoglobinuria*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Sodium, serum-high (hypernatremia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE:: Muscle weakness, generalized or specific area
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: (not due to neuropathy):: Whole body/generalized\*3
Frequency: 3 affected / 26 at risk

Adverse event: NEUROLOGY:: Mood alteration:: Agitation*3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: NEUROLOGY:: Neuropathy: motor*3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nasal congestion*4
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Neck pain*4
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nervous system disorders - Other, specify*4
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Neutrophil count decreased*4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Non-cardiac chest pain*4
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain - Other (Burning sensation waist & tumor area)*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain:: Chest/thorax NOS*3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain:: Pelvis*3
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 26 at risk

Adverse event: PAIN:: Pain:: Throat/pharynx/larynx*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Nasal cavity/paranasal sinus reactions*3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Pleural effusion (non-malignant)*3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain*4
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Peripheral motor neuropathy*4
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pleural effusion*4
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pruritus*4
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: SYNDROMES:: Flu-like syndrome*3
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 26 at risk

Adverse event: Sinus bradycardia*4
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Surgical and medical procedures - Other, specify*4
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 26 at risk

Adverse event: Vomiting*4
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Weight gain*4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Wound dehiscence*4
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 26 at risk

Adverse event: Wound infection*4
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)*3
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 26 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fatigue (asthenia, lethargy, malaise)*3
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 26 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia,
Serious: yes
Organ System: General disorders
Notes: where neutropenia is defined as ANC \<1.0 x 10e9/L)\*3
Frequency: 13 affected / 26 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Insomnia*3
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Rigors/chills*3
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)*3
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: DEATH:: Death not associated with CTCAE term:: Disease progression NOS*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes*3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 26 at risk

Adverse event: DERMATOLOGY/SKIN:: Nail changes*3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 26 at risk

Adverse event: DERMATOLOGY/SKIN:: Rash/desquamation*3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal - Other (Partial bowel obstruction)*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Urinary tract NOS*3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: ALT, SGPT (serum glutamic pyruvic transaminase)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: AST, SGOT(serum glutamic oxaloacetic transaminase)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Alkaline phosphatase*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Bilirubin (hyperbilirubinemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: CPK (creatine phosphokinase)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Calcium, serum-low (hypocalcemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Cholesterol, serum-high (hypercholesteremia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Glucose, serum-high (hyperglycemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Magnesium, serum-high (hypermagnesemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Magnesium, serum-low (hypomagnesemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Phosphate, serum-low (hypophosphatemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Potassium, serum-high (hyperkalemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Potassium, serum-low (hypokalemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Proteinuria*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Sodium, serum-low (hyponatremia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Uric acid, serum-high (hyperuricemia)*3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: NEUROLOGY:: Dizziness*3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: NEUROLOGY:: Mood alteration:: Depression*3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain:: Abdomen NOS*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 26 at risk

Adverse event: PAIN:: Pain:: Back*3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 26 at risk

Adverse event: PAIN:: Pain:: Bone*3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: PAIN:: Pain:: Chest wall*3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain:: Extremity-limb*3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 26 at risk

Adverse event: PAIN:: Pain:: Eye*3
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain:: Head/headache*3
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 26 at risk

Adverse event: PAIN:: Pain:: Muscle*3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 26 at risk

Adverse event: PAIN:: Pain:: Stomach*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Cough*3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 26 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Dyspnea (shortness of breath)*3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: RENAL/GENITOURINARY:: Urinary frequency/urgency*3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dermatology/Skin - Other (Mouth sore-lower lip)*3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal - Other (Emesis)*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal - Other (Erythema Mucosa-Under tongue & hard palate)*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal - Other (Gastroesophageal reflux disease )*3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain - Other (Right inguinal pain)*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain - Other (Rt. thigh pain)*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain - Other (Sternum pain)*3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)*3
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Activated partial thromboplastin time prolonged*4
Serious: no
Organ System: Investigations
Frequency: 4 affected / 26 at risk

Adverse event: Alanine aminotransferase increased*4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Alkaline phosphatase increased*4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Allergic reaction*4
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Allergic rhinitis*4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Anemia*4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Aspartate aminotransferase increased*4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: BLOOD/BONE MARROW:: Hemoglobin*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: BLOOD/BONE MARROW:: Leukocytes (total WBC)*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 26 at risk

Adverse event: BLOOD/BONE MARROW:: Lymphopenia*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: BLOOD/BONE MARROW:: Platelets*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Back pain*4
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Bruising*4
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 26 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus tachycardia*3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fatigue (asthenia, lethargy, malaise)*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS
Serious: no
Organ System: General disorders
Notes: Fever (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)\*3
Frequency: 10 affected / 26 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Insomnia*3
Serious: no
Organ System: General disorders
Frequency: 13 affected / 26 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Rigors/chills*3
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)*3
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Weight gain*3
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: CPK increased*4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Creatinine increased*4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Cystitis noninfective*4
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: DERMATOLOGY/SKIN:: Dermatology/Skin - Other (Allergic reaction-Tape )*3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: DERMATOLOGY/SKIN:: Dry skin*3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes*3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: DERMATOLOGY/SKIN:: Pruritus/itching*3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 26 at risk

Adverse event: DERMATOLOGY/SKIN:: Rash/desquamation*3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 26 at risk

Adverse event: Delirium*4
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Depression*4
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhea*4
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Fall*4
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 26 at risk

Adverse event: Fever*4
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Anorexia*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Constipation*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Diarrhea*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Distension/bloating, abdominal*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Dysphagia (difficulty swallowing)*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Heartburn/dyspepsia*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Nausea*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Vomiting*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 26 at risk

Adverse event: Gingival pain*4
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Urinary NOS*3
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage/Bleeding - Other (Spotting )*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hallucinations*4
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Headache*4
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hyperglycemia*4
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hyperuricemia*4
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypoalbuminemia*4
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypoglycemia*4
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypomagnesemia*4
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypophosphatemia*4
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: INFECTION:: Infection - Other (Lt. lower leg, redness, swelling & whelts)*3
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Lung (pneumonia)*3
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Urinary tract NOS*3
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Injection site reaction*4
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: LYMPHATICS:: Edema: limb*3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Lipase increased*4
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Lymphocyte count decreased*4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: ALT, SGPT (serum glutamic pyruvic transaminase)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: AST, SGOT(serum glutamic oxaloacetic transaminase)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Alkaline phosphatase*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Bilirubin (hyperbilirubinemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: CPK (creatine phosphokinase)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Calcium, serum-high (hypercalcemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Calcium, serum-low (hypocalcemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Cholesterol, serum-high (hypercholesteremia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Glucose, serum-high (hyperglycemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Glucose, serum-low (hypoglycemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Hemoglobinuria*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Magnesium, serum-high (hypermagnesemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Magnesium, serum-low (hypomagnesemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Phosphate, serum-low (hypophosphatemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Potassium, serum-high (hyperkalemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Potassium, serum-low (hypokalemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Proteinuria*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Sodium, serum-high (hypernatremia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Sodium, serum-low (hyponatremia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC/LABORATORY:: Uric acid, serum-high (hyperuricemia)*3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 26 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Muscle weakness, generalized or specific area (not due to neuropathy):: Whole body/generalized\*3
Frequency: 2 affected / 26 at risk

Adverse event: NEUROLOGY:: Dizziness*3
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 26 at risk

Adverse event: NEUROLOGY:: Mood alteration:: Agitation*3
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: NEUROLOGY:: Mood alteration:: Depression*3
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: NEUROLOGY:: Neuropathy: motor*3
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nasal congestion*4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Neck pain*4
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nervous system disorders - Other, specify*4
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Neutrophil count decreased*4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Non-cardiac chest pain*4
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain - Other (Burning sensation waist & tumor area)*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain:: Abdomen NOS*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: PAIN:: Pain:: Back*3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 26 at risk

Adverse event: PAIN:: Pain:: Bone*3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 26 at risk

Adverse event: PAIN:: Pain:: Chest wall*3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: PAIN:: Pain:: Chest/thorax NOS*3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain:: Extremity-limb*3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain:: Eye*3
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 26 at risk

Adverse event: PAIN:: Pain:: Head/headache*3
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain:: Muscle*3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 26 at risk

Adverse event: PAIN:: Pain:: Pelvis*3
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 26 at risk

Adverse event: PAIN:: Pain:: Stomach*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: PAIN:: Pain:: Throat/pharynx/larynx*3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Cough*3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Dyspnea (shortness of breath)*3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 26 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Nasal cavity/paranasal sinus reactions*3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain*4
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Peripheral motor neuropathy*4
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pruritus*4
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: RENAL/GENITOURINARY:: Urinary frequency/urgency*3
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: SYNDROMES:: Flu-like syndrome*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Sinus bradycardia*4
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 26 at risk

Adverse event: Vomiting*4
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Weight gain*4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Wound dehiscence*4
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 26 at risk

Adverse event: Wound infection*4
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 26 at risk

Adverse event: DERMATOLOGY/SKIN:: Dermatology/Skin - Other (Mouth sore-lower lip)*3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal - Other (Emesis)*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal - Other (Erythema mucosa-under tongue & hard palate )*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal - Other (Gastroesophageal reflux disease)*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal - Other (Partial bowel obstruction)*3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain - Other (Right inguinal pain)*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain - Other (Rt. thigh pain)*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: PAIN:: Pain - Other (Sternum pain)*3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk