Study: NCT01034631

Adverse event: CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: PERICARDIAL EFFUSION (NON-MALIGNANT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 15 at risk

Adverse event: ACIDOSIS (METABOLIC OR RESPIRATORY)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 5 affected / 15 at risk

Adverse event: ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 15 at risk

Adverse event: ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 15 at risk

Adverse event: ALLERGY/IMMUNOLOGY
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 15 at risk

Adverse event: ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: ARTHRITIS (NON-SEPTIC)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: ASCITES (NON-MALIGNANT)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: AUDITORY/EAR
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 15 at risk

Adverse event: BICARBONATE, SERUM-LOW
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: BLOOD/BONE MARROW
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: CALCIUM, SERUM-LOW (HYPOCALCEMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: CARDIAC GENERAL
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: CERVICAL SPINE-RANGE OF MOTION
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 15 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 15 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 15 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 5 affected / 15 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: DENTAL: TEETH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: DERMATOLOGY/SKIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 15 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: EDEMA: HEAD AND NECK
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 15 at risk

Adverse event: ENDOCRINE
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 15 at risk

Adverse event: FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 15 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: GASTROINTESTINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: HAIR LOSS/ALOPECIA (SCALP OR BODY)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 15 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: HOT FLASHES/FLUSHES
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk

Adverse event: HYPERPIGMENTATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 15 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: INCONTINENCE, ANAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: INCONTINENCE, URINARY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / SKIN (CELLULITES)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / ORAL CAVITY-GUMS (GINGIVITIS)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SINUS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 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 / 15 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UNGUAL (NAILS)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AIRWAY NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / SINUS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 15 at risk

Adverse event: LIVER DYSFUNCTION/FAILURE (CLINICAL)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 15 at risk

Adverse event: MAGNESIUM, SERUM-HIGH (HYPERMAGNESEMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: METABOLIC/LABORATORY
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: MOOD ALTERATION / ANXIETY
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 15 at risk

Adverse event: MOOD ALTERATION / DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 15 at risk

Adverse event: MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 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: 2 affected / 15 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 15 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: NASAL CAVITY/PARANASAL SINUS REACTIONS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 15 at risk

Adverse event: NEUROENDOCRINE: ADH SECRETION ABNORMALITY (E.G., SIADH OR LOW ADH)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk

Adverse event: NEUROLOGY
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: OCULAR/VISUAL
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 15 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: PAIN / ABDOMEN NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: PAIN / BACK
Serious: no
Organ System: General disorders
Frequency: 6 affected / 15 at risk

Adverse event: PAIN / BONE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: PAIN / BREAST
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk

Adverse event: PAIN / CHEST WALL
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 15 at risk

Adverse event: PAIN / CHEST/THORAX NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: PAIN / EXTREMITY-LIMB
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 15 at risk

Adverse event: PAIN / HEAD/HEADACHE
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: PAIN / JOINT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 15 at risk

Adverse event: PAIN / MUSCLE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: PAIN / ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: PAIN / STOMACH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: PAIN / THROAT/PHARYNX/LARYNX
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 15 at risk

Adverse event: PANCREATIC ENDOCRINE: GLUCOSE INTOLERANCE
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 15 at risk

Adverse event: PERICARDIAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 15 at risk

Adverse event: PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 15 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 15 at risk

Adverse event: PNEUMONITIS/PULMONARY INFILTRATES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: POTASSIUM, SERUM-LOW (HYPOKALEMIA)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 4 affected / 15 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 15 at risk

Adverse event: PTT (PARTIAL THROMBOPLASTIN TIME)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 15 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: RASH: ACNE/ACNEIFORM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: RENAL/GENITOURINARY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 15 at risk

Adverse event: RIGORS/CHILLS
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Seroma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: SODIUM, SERUM-HIGH (HYPERNATREMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: SODIUM, SERUM-LOW (HYPONATREMIA)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 15 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: SWEATING (DIAPHORESIS)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

Adverse event: THYROID FUNCTION, HIGH (HYPERTHYROIDISM, THYROTOXICOSIS)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk

Adverse event: THYROID FUNCTION, LOW (HYPOTHYROIDISM)
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 15 at risk

Adverse event: TRIGLYCERIDE, SERUM-HIGH (HYPERTRIGLYCERIDEMIA)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 15 at risk

Adverse event: ULCER, GI / DUODENUM
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: URINE COLOR CHANGE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: URTICARIA (HIVES, WELTS, WHEALS)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: VASCULAR
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

Adverse event: VISION-BLURRED VISION
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 15 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 15 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 7 affected / 15 at risk

Adverse event: ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 70 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: GASTROINTESTINAL
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 70 at risk

Adverse event: INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / RECTUM
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: PAIN / BACK
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 70 at risk

Adverse event: PAIN / BONE
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: PAIN / CHEST/THORAX NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: PAIN / NECK
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: PNEUMONITIS/PULMONARY INFILTRATES
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: RENAL/GENITOURINARY
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 70 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 70 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 70 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: VASCULAR
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 70 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: ACIDOSIS (METABOLIC OR RESPIRATORY)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 70 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 10 affected / 70 at risk

Adverse event: ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 70 at risk

Adverse event: ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 70 at risk

Adverse event: ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 70 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 70 at risk

Adverse event: ARTHRITIS (NON-SEPTIC)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 70 at risk

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 9 affected / 70 at risk

Adverse event: AUTOIMMUNE REACTION
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 70 at risk

Adverse event: BLOOD/BONE MARROW
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 70 at risk

Adverse event: BRONCHOSPASM, WHEEZING
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 70 at risk

Adverse event: CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 70 at risk

Adverse event: CALCIUM, SERUM-LOW (HYPOCALCEMIA)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 70 at risk

Adverse event: CARDIAC GENERAL
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 70 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 70 at risk

Adverse event: CHELITIS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
Serious: no
Organ System: Investigations
Frequency: 22 affected / 70 at risk

Adverse event: COAGULATION
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 70 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 70 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS
Serious: no
Organ System: General disorders
Frequency: 3 affected / 70 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 70 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 15 affected / 70 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: DENTAL: TEETH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: DERMATOLOGY/SKIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 70 at risk

Adverse event: DISTENSION/BLOATING, ABDOMINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 70 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 70 at risk

Adverse event: DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 70 at risk

Adverse event: DYSPHAGIA (DIFFICULTY SWALLOWING)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 70 at risk

Adverse event: EDEMA: HEAD AND NECK
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 70 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 70 at risk

Adverse event: ENDOCRINE
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 70 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 70 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 42 affected / 70 at risk

Adverse event: FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 70 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 70 at risk

Adverse event: GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: GASTROINTESTINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 70 at risk

Adverse event: GGT (GAMMA-GLUTAMYL TRANSPEPTIDASE)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
Serious: no
Organ System: Investigations
Frequency: 19 affected / 70 at risk

Adverse event: GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 70 at risk

Adverse event: HAIR LOSS/ALOPECIA (SCALP OR BODY)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 70 at risk

Adverse event: HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 70 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 70 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 35 affected / 70 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 70 at risk

Adverse event: HEMORRHAGE, GI / RECTUM
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: HEMORRHAGE, GU / URINARY NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 70 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 70 at risk

Adverse event: HEMORRHAGE/BLEEDING
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: HOT FLASHES/FLUSHES
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 70 at risk

Adverse event: HYPERPIGMENTATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 70 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 70 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: INCONTINENCE, ANAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: INCONTINENCE, URINARY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 70 at risk

Adverse event: INFECTIONWITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / SINUS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 70 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / ABDOMEN NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BRONCHUS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / EXTERNAL EAR (OTITIS EXTERNA)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / EYE NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LARYNX
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SINUS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 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 / 70 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AIRWAY NOS
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 70 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 70 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / SKIN (CELLULITES)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 70 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / UPPER AIRWAY NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / VAGINA
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 70 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 70 at risk

Adverse event: JOINT-FUNCTION
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 70 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 70 at risk

Adverse event: LYMPHATICS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 70 at risk

Adverse event: MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: METABOLIC/LABORATORY
Serious: no
Organ System: Investigations
Frequency: 9 affected / 70 at risk

Adverse event: MOOD ALTERATION / AGITATION
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 70 at risk

Adverse event: MOOD ALTERATION / ANXIETY
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 70 at risk

Adverse event: MOOD ALTERATION / DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 70 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
Serious: no
Organ System: Surgical and medical procedures
Frequency: 13 affected / 70 at risk

Adverse event: MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 70 at risk

Adverse event: MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTRAOCULAR
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 70 at risk

Adverse event: MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 70 at risk

Adverse event: MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-UPPER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 70 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: 3 affected / 70 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 70 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 70 at risk

Adverse event: NASAL CAVITY/PARANASAL SINUS REACTIONS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 70 at risk

Adverse event: NEUROLOGY
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: NEUROPATHY: MOTOR
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 70 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 70 at risk

Adverse event: Obesity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 70 at risk

Adverse event: OCULAR/VISUAL
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 70 at risk

Adverse event: PAIN / ABDOMEN NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 70 at risk

Adverse event: PAIN / ANUS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: PAIN / BACK
Serious: no
Organ System: General disorders
Frequency: 15 affected / 70 at risk

Adverse event: PAIN / BONE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 70 at risk

Adverse event: PAIN / BREAST
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 70 at risk

Adverse event: PAIN / BUTTOCK
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: PAIN / CHEST WALL
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 70 at risk

Adverse event: PAIN / CHEST/THORAX NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 70 at risk

Adverse event: PAIN / EXTERNAL EAR
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 70 at risk

Adverse event: PAIN / EXTREMITY-LIMB
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 70 at risk

Adverse event: PAIN / EYE
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 70 at risk

Adverse event: PAIN / FACE
Serious: no
Organ System: General disorders
Frequency: 2 affected / 70 at risk

Adverse event: PAIN / HEAD/HEADACHE
Serious: no
Organ System: General disorders
Frequency: 7 affected / 70 at risk

Adverse event: PAIN / JOINT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 70 at risk

Adverse event: PAIN / KIDNEY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 70 at risk

Adverse event: PAIN / LIP
Serious: no
Organ System: General disorders
Frequency: 2 affected / 70 at risk

Adverse event: PAIN / MUSCLE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 70 at risk

Adverse event: PAIN / NECK
Serious: no
Organ System: General disorders
Frequency: 3 affected / 70 at risk

Adverse event: PAIN / PHANTOM (PAIN ASSOCIATED WITH MISSING LIMB)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: PAIN / SCALP
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: PAIN / STOMACH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: PAIN / THROAT/PHARYNX/LARYNX
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: PAIN / TUMOR PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 70 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: PANCREATIC ENDOCRINE: GLUCOSE INTOLERANCE
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 70 at risk

Adverse event: PERSONALITY/BEHAVIORAL
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 70 at risk

Adverse event: PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 70 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 70 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: PNEUMONITIS/PULMONARY INFILTRATES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 70 at risk

Adverse event: POTASSIUM, SERUM-LOW (HYPOKALEMIA)
Serious: no
Organ System: Investigations
Frequency: 9 affected / 70 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 11 affected / 70 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 70 at risk

Adverse event: PTT (PARTIAL THROMBOPLASTIN TIME)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 70 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 70 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 70 at risk

Adverse event: RASH: ACNE/ACNEIFORM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 70 at risk

Adverse event: RASH: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 70 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 70 at risk

Adverse event: RENAL/GENITOURINARY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 70 at risk

Adverse event: RIGORS/CHILLS
Serious: no
Organ System: General disorders
Frequency: 3 affected / 70 at risk

Adverse event: SALIVARY GLAND CHANGES/SALIVA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: SODIUM, SERUM-HIGH (HYPERNATREMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: SODIUM, SERUM-LOW (HYPONATREMIA)
Serious: no
Organ System: Investigations
Frequency: 10 affected / 70 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS BRADYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: SWEATING (DIAPHORESIS)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 70 at risk

Adverse event: SYNDROMES
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 70 at risk

Adverse event: THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 70 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 70 at risk

Adverse event: THYROID FUNCTION, HIGH (HYPERTHYROIDISM, THYROTOXICOSIS)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 70 at risk

Adverse event: THYROID FUNCTION, LOW (HYPOTHYROIDISM)
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 70 at risk

Adverse event: TRIGLYCERIDE, SERUM-HIGH (HYPERTRIGLYCERIDEMIA)
Serious: no
Organ System: Investigations
Frequency: 21 affected / 70 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: URINARY FREQUENCY/URGENCY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 70 at risk

Adverse event: URINE COLOR CHANGE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 70 at risk

Adverse event: VAGINITIS (NOT DUE TO INFECTION)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 70 at risk

Adverse event: VISION-BLURRED VISION
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 70 at risk

Adverse event: VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 70 at risk

Adverse event: WATERY EYE (EPIPHORA, TEARING)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 70 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 70 at risk

Adverse event: CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 69 at risk

Adverse event: CARDIAC GENERAL
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 69 at risk

Adverse event: DEATH NOT ASSOCIATED WITH CTCAE TERM / MULTI-ORGAN FAILURE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 69 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 69 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: GASTROINTESTINAL
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 69 at risk

Adverse event: GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 69 at risk

Adverse event: HEMORRHAGE, GU / URINARY NOS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 69 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 69 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 69 at risk

Adverse event: LYMPHATICS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 69 at risk

Adverse event: MENTAL STATUS
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 69 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: OBSTRUCTION, GI / SMALL BOWEL NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: PAIN / BACK
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: PAIN / BONE
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 69 at risk

Adverse event: PAIN / JOINT
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: PAIN / TUMOR PAIN
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 69 at risk

Adverse event: PNEUMONITIS/PULMONARY INFILTRATES
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 69 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 69 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 69 at risk

Adverse event: RENAL/GENITOURINARY
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 69 at risk

Adverse event: SODIUM, SERUM-LOW (HYPONATREMIA)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 69 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 69 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 69 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 69 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 14 affected / 69 at risk

Adverse event: ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 69 at risk

Adverse event: ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 69 at risk

Adverse event: ALLERGY/IMMUNOLOGY
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 69 at risk

Adverse event: ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 69 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 69 at risk

Adverse event: ARTHRITIS (NON-SEPTIC)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 69 at risk

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 9 affected / 69 at risk

Adverse event: ATAXIA (INCOORDINATION)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 69 at risk

Adverse event: AUDITORY/EAR
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 69 at risk

Adverse event: BICARBONATE, SERUM-LOW
Serious: no
Organ System: Investigations
Frequency: 2 affected / 69 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: BLOOD/BONE MARROW
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 69 at risk

Adverse event: BRONCHOSPASM, WHEEZING
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 69 at risk

Adverse event: CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 69 at risk

Adverse event: CALCIUM, SERUM-LOW (HYPOCALCEMIA)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 69 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 69 at risk

Adverse event: CARDIAC GENERAL
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 69 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 69 at risk

Adverse event: CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
Serious: no
Organ System: Investigations
Frequency: 30 affected / 69 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 69 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 69 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS
Serious: no
Organ System: General disorders
Frequency: 6 affected / 69 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 69 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 13 affected / 69 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 69 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 69 at risk

Adverse event: DENTAL: TEETH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: DERMATOLOGY/SKIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 69 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 69 at risk

Adverse event: DISTENSION/BLOATING, ABDOMINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 69 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 69 at risk

Adverse event: DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 69 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 69 at risk

Adverse event: DYSPHAGIA (DIFFICULTY SWALLOWING)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 69 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 69 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 69 at risk

Adverse event: EDEMA: TRUNK/GENITAL
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 69 at risk

Adverse event: ENDOCRINE
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 69 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 69 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 69 at risk

Adverse event: EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 69 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 46 affected / 69 at risk

Adverse event: FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
Serious: no
Organ System: General disorders
Frequency: 13 affected / 69 at risk

Adverse event: FIBROSIS-DEEP CONNECTIVE TISSUE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 69 at risk

Adverse event: GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 69 at risk

Adverse event: GASTROINTESTINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 69 at risk

Adverse event: GGT (GAMMA-GLUTAMYL TRANSPEPTIDASE)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 69 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 69 at risk

Adverse event: GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
Serious: no
Organ System: Investigations
Frequency: 24 affected / 69 at risk

Adverse event: GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 69 at risk

Adverse event: HAIR LOSS/ALOPECIA (SCALP OR BODY)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 69 at risk

Adverse event: HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 69 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 69 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 38 affected / 69 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 69 at risk

Adverse event: HEMORRHAGE, GU / URINARY NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 69 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / BRONCHOPULMONARY NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / LUNG
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 69 at risk

Adverse event: HEMORRHAGE/BLEEDING
Serious: no
Organ System: General disorders
Frequency: 3 affected / 69 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 69 at risk

Adverse event: HICCOUGHS (HICCUPS, SINGULTUS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: HOT FLASHES/FLUSHES
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 69 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 69 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 69 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 69 at risk

Adverse event: ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: INCONTINENCE, URINARY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 69 at risk

Adverse event: INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / BLADDER (URINARY)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: INFECTIONWITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / URINARY TRACT NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BRONCHUS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 69 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SINUS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 69 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 / 69 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AIRWAY NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / SINUS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 69 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 69 at risk

Adverse event: JOINT-FUNCTION
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 69 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 69 at risk

Adverse event: Lipase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: LUMBAR SPINE-RANGE OF MOTION
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: LYMPHATICS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 69 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 69 at risk

Adverse event: MAGNESIUM, SERUM-HIGH (HYPERMAGNESEMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 69 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 69 at risk

Adverse event: METABOLIC/LABORATORY
Serious: no
Organ System: Investigations
Frequency: 11 affected / 69 at risk

Adverse event: MOOD ALTERATION / AGITATION
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 69 at risk

Adverse event: MOOD ALTERATION / ANXIETY
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 69 at risk

Adverse event: MOOD ALTERATION / DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 69 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
Serious: no
Organ System: Surgical and medical procedures
Frequency: 21 affected / 69 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) / PHARYNX
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 69 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) / STOMACH
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 69 at risk

Adverse event: MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 69 at risk

Adverse event: MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 69 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: 3 affected / 69 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 69 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 69 at risk

Adverse event: NASAL CAVITY/PARANASAL SINUS REACTIONS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 69 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 69 at risk

Adverse event: NEUROLOGY
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 69 at risk

Adverse event: NEUROPATHY: MOTOR
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 69 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 69 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 69 at risk

Adverse event: OCULAR/VISUAL
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 69 at risk

Adverse event: PAIN / ABDOMEN NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 69 at risk

Adverse event: PAIN / BACK
Serious: no
Organ System: General disorders
Frequency: 22 affected / 69 at risk

Adverse event: PAIN / BONE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 69 at risk

Adverse event: PAIN / BUTTOCK
Serious: no
Organ System: General disorders
Frequency: 3 affected / 69 at risk

Adverse event: PAIN / CARDIAC/HEART
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 69 at risk

Adverse event: PAIN / CHEST WALL
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 69 at risk

Adverse event: PAIN / CHEST/THORAX NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 69 at risk

Adverse event: PAIN / EXTERNAL EAR
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 69 at risk

Adverse event: PAIN / EXTREMITY-LIMB
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 69 at risk

Adverse event: PAIN / FACE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: PAIN / HEAD/HEADACHE
Serious: no
Organ System: General disorders
Frequency: 17 affected / 69 at risk

Adverse event: PAIN / JOINT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 69 at risk

Adverse event: PAIN / KIDNEY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 69 at risk

Adverse event: PAIN / MUSCLE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 69 at risk

Adverse event: PAIN / NECK
Serious: no
Organ System: General disorders
Frequency: 2 affected / 69 at risk

Adverse event: PAIN / ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 69 at risk

Adverse event: PAIN / ORAL-GUMS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 69 at risk

Adverse event: PAIN / PAIN NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: PAIN / PELVIS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 69 at risk

Adverse event: PAIN / SCALP
Serious: no
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: PAIN / THROAT/PHARYNX/LARYNX
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 69 at risk

Adverse event: PAIN / URETHRA
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 69 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 69 at risk

Adverse event: PANCREATIC ENDOCRINE: GLUCOSE INTOLERANCE
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 69 at risk

Adverse event: PERICARDIAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 69 at risk

Adverse event: PERSONALITY/BEHAVIORAL
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 69 at risk

Adverse event: PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 69 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 69 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 69 at risk

Adverse event: PNEUMONITIS/PULMONARY INFILTRATES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 69 at risk

Adverse event: POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 69 at risk

Adverse event: POTASSIUM, SERUM-LOW (HYPOKALEMIA)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 69 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 12 affected / 69 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 69 at risk

Adverse event: PSYCHOSIS (HALLUCINATIONS/DELUSIONS)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 69 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 69 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 69 at risk

Adverse event: RASH: ACNE/ACNEIFORM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 69 at risk

Adverse event: RASH: DERMATITIS ASSOCIATED WITH RADIATION / RADIATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: RASH: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 69 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 69 at risk

Adverse event: RENAL/GENITOURINARY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 69 at risk

Adverse event: RIGORS/CHILLS
Serious: no
Organ System: General disorders
Frequency: 6 affected / 69 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 69 at risk

Adverse event: SODIUM, SERUM-HIGH (HYPERNATREMIA)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 69 at risk

Adverse event: SODIUM, SERUM-LOW (HYPONATREMIA)
Serious: no
Organ System: Investigations
Frequency: 12 affected / 69 at risk

Adverse event: STRICTURE/STENOSIS (INCLUDING ANASTOMOTIC), GU / PROSTATE
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 69 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS TACHYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 69 at risk

Adverse event: SWEATING (DIAPHORESIS)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 69 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 69 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 69 at risk

Adverse event: THYROID FUNCTION, HIGH (HYPERTHYROIDISM, THYROTOXICOSIS)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 69 at risk

Adverse event: THYROID FUNCTION, LOW (HYPOTHYROIDISM)
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 69 at risk

Adverse event: TRIGLYCERIDE, SERUM-HIGH (HYPERTRIGLYCERIDEMIA)
Serious: no
Organ System: Investigations
Frequency: 28 affected / 69 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 69 at risk

Adverse event: URIC ACID, SERUM-HIGH (HYPERURICEMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: URINARY FREQUENCY/URGENCY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 69 at risk

Adverse event: VASCULAR
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 69 at risk

Adverse event: VESSEL INJURY-VEIN / SVC
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 69 at risk

Adverse event: VISION-BLURRED VISION
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 69 at risk

Adverse event: VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 69 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 69 at risk

Adverse event: WATERY EYE (EPIPHORA, TEARING)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 69 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 13 affected / 69 at risk