Study: NCT00216099

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: DIC (DISSEMINATED INTRAVASCULAR COAGULATION)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: FEBRILE NEUTROPENIA(ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: HEMORRHAGE, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: HEPATOBILIARY/PANCREAS - OTHER
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / CATHETER-RELATED
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / SKIN (CELLULITES)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / BONE
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / CARDIAC/HEART
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / PELVIS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: PLATELETS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: VESSEL INJURY-ARTERY / EXTREMITY-LOWER
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: VESSEL INJURY-VEIN / EXTREMITY-LOWER
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 49 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 7 affected / 49 at risk

Adverse event: ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 49 at risk

Adverse event: ALLERGY/IMMUNOLOGY - OTHER
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 49 at risk

Adverse event: ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 49 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 49 at risk

Adverse event: ARTHRITIS (NON-SEPTIC)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 49 at risk

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 49 at risk

Adverse event: CARDIAC ARRHYTHMIA - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: CARDIAC GENERAL - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 49 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS - OTHER
Serious: no
Organ System: General disorders
Frequency: 4 affected / 49 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 49 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 7 affected / 49 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: DERMATOLOGY/SKIN - OTHER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 49 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 49 at risk

Adverse event: DISTENSION/BLOATING, ABDOMINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 49 at risk

Adverse event: DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 49 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 49 at risk

Adverse event: EDEMA: TRUNK/GENITAL
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 49 at risk

Adverse event: EXTREMITY-LOWER (GAIT/WALKING)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: EXTREMITY-UPPER (FUNCTION)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 41 affected / 49 at risk

Adverse event: FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 49 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 / 49 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 49 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk

Adverse event: HAIR LOSS/ALOPECIA (SCALP OR BODY)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 49 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 49 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 49 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Investigations
Frequency: 1 affected / 49 at risk

Adverse event: HEMORRHAGE, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: HEMORRHAGE, GI / ANUS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: HOT FLASHES/FLUSHES
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 49 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 49 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: INCONTINENCE, URINARY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION - OTHER
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 49 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BLADDER (URINARY)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 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 / 49 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / ABDOMEN NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / BLADDER (URINARY)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / LYMPHATIC
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / SKIN (CELLULITES)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / UPPER AIRWAY NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 49 at risk

Adverse event: INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 49 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 49 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 49 at risk

Adverse event: LUMBAR SPINE-RANGE OF MOTION
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: LYMPHATICS - OTHER
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: MOOD ALTERATION / AGITATION
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: MOOD ALTERATION / ANXIETY
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 49 at risk

Adverse event: MOOD ALTERATION / DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 49 at risk

Adverse event: MOOD ALTERATION / ANXIETY
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 49 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 49 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: 1 affected / 49 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 / 49 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: NASAL CAVITY/PARANASAL SINUS REACTIONS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 49 at risk

Adverse event: NEUROLOGY - OTHER
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: NEUROPATHY: MOTOR
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 49 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 49 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 49 at risk

Adverse event: OBSTRUCTION, GU / PROSTATE
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk

Adverse event: OCULAR/VISUAL - OTHER
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 49 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / ABDOMEN NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: PAIN / BACK
Serious: no
Organ System: General disorders
Frequency: 13 affected / 49 at risk

Adverse event: PAIN / BLADDER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / BONE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 49 at risk

Adverse event: PAIN / BREAST
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / CHEST/THORAX NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / EXTREMITY-LIMB
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 49 at risk

Adverse event: PAIN / EXTREMITY-LIMB- HAND
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / EYE
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / HEAD/HEADACHE
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: PAIN / INTESTINE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / JOINT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 49 at risk

Adverse event: PAIN / MUSCLE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 49 at risk

Adverse event: PAIN / NEURALGIA/PERIPHERAL NERVE
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / PERINEUM
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / PROSTATE
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / RECTUM
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / SCALP
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / STOMACH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN - OTHER
Serious: no
Organ System: General disorders
Frequency: 5 affected / 49 at risk

Adverse event: PAIN - OTHER FEET
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / BACK
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: PAIN / EXTREMITY-LIMB
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: PAIN / EYE
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN / JOINT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 49 at risk

Adverse event: PAIN / PELVIS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 49 at risk

Adverse event: PETECHIAE/PURPURA (HEMORRHAGE/BLEEDING INTO SKIN OR MUCOSA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: PETECHIAE/PURPURA (HEMORRHAGE/BLEEDING INTO SKIN OR MUCOSA)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 49 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 49 at risk

Adverse event: PTT (PARTIAL THROMBOPLASTIN TIME)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 49 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - OTHER
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 49 at risk

Adverse event: RASH: ACNE/ACNEIFORM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 49 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: 3 affected / 49 at risk

Adverse event: RASH: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: RENAL/GENITOURINARY - OTHER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: RIGORS/CHILLS
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: SODIUM, SERUM-LOW (HYPONATREMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 49 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 49 at risk

Adverse event: URINARY FREQUENCY/URGENCY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 49 at risk

Adverse event: URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 49 at risk

Adverse event: URINE COLOR CHANGE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: VISION-BLURRED VISION
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 49 at risk

Adverse event: WATERY EYE (EPIPHORA, TEARING)
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 49 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk