Study: NCT00862719

Adverse event: LYMPHATICS - OTHER
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 at risk

Adverse event: CARDIAC ARRHYTHMIA - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 17 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: PAIN - ABDOMEN NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 17 at risk

Adverse event: FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 17 at risk

Adverse event: INFECTION - OTHER
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 17 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BRONCHUS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - SINUS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: CERVICAL SPINE-RANGE OF MOTION
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: PAIN - EXTREMITY-LIMB
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: PAIN - HEAD/HEADACHE
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: EDEMA, LARYNX
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 17 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - OTHER
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: HEMORRHAGE, GI - ABDOMEN NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk

Adverse event: HEMORRHAGE, GI - LOWER GI NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - LUNG
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - RESPIRATORY TRACT NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk

Adverse event: BLOOD/BONE MARROW - OTHER
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 at risk

Adverse event: COAGULATION - OTHER
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 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 / 17 at risk

Adverse event: LYMPHATICS - OTHER
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 17 at risk

Adverse event: CARDIAC ARRHYTHMIA - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 17 at risk

Adverse event: CARDIAC GENERAL - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 17 at risk

Adverse event: PERICARDIAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 17 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 17 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 17 at risk

Adverse event: VALVULAR HEART DISEASE
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: VENTRICULAR ARRHYTHMIA - VENTRICULAR TACHYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: AUDITORY/EAR - OTHER
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 17 at risk

Adverse event: PAIN - MIDDLE EAR
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 17 at risk

Adverse event: THYROID FUNCTION, LOW (HYPOTHYROIDISM)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: OPHTHALMOPLEGIA/DIPLOPIA (DOUBLE VISION)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: PAIN - EYE
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: VISION-BLURRED VISION
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 17 at risk

Adverse event: VISION-FLASHING LIGHTS/FLOATERS
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: ASCITES (NON-MALIGNANT)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 17 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: COLITIS, INFECTIOUS (E.G., CLOSTRIDIUM DIFFICILE)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 17 at risk

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

Adverse event: DISTENSION/BLOATING, ABDOMINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 17 at risk

Adverse event: DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: DYSPHAGIA (DIFFICULTY SWALLOWING)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: HICCOUGHS (HICCUPS, SINGULTUS)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ESOPHAGUS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 17 at risk

Adverse event: MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 17 at risk

Adverse event: OBSTRUCTION, GI - STOMACH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: OCULAR/VISUAL - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: PAIN - ABDOMEN NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 17 at risk

Adverse event: PAIN - RECTUM
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 17 at risk

Adverse event: EDEMA: HEAD AND NECK
Serious: no
Organ System: General disorders
Frequency: 3 affected / 17 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: General disorders
Frequency: 12 affected / 17 at risk

Adverse event: EDEMA: TRUNK/GENITAL
Serious: no
Organ System: General disorders
Frequency: 5 affected / 17 at risk

Adverse event: EDEMA: VISCERA
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 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: 14 affected / 17 at risk

Adverse event: PAIN - CHEST WALL
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: PAIN - CHEST/THORAX NOS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: PAIN - OTHER
Serious: no
Organ System: General disorders
Frequency: 11 affected / 17 at risk

Adverse event: PAIN - PAIN NOS
Serious: no
Organ System: General disorders
Frequency: 3 affected / 17 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 17 at risk

Adverse event: HEPATOBILIARY/PANCREAS - OTHER
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 17 at risk

Adverse event: LIVER DYSFUNCTION/FAILURE (CLINICAL)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 17 at risk

Adverse event: ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 17 at risk

Adverse event: ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 17 at risk

Adverse event: Serum sickness
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 17 at risk

Adverse event: FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 17 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 17 at risk

Adverse event: INFECTION - OTHER
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 17 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - ANAL/PERIANAL
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - COLON
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 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 / 17 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - PARANASAL
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 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 / 17 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SMALL BOWEL NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 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 / 17 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - BLADDER (URINARY)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - COLON
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - EYE NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - MIDDLE EAR (OTITIS MEDIA)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - SINUS
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 17 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - SKIN (CELLULITIS)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 17 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: WOUND COMPLICATION, NON-INFECTIOUS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 17 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 15 affected / 17 at risk

Adverse event: ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 17 affected / 17 at risk

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 17 affected / 17 at risk

Adverse event: BICARBONATE, SERUM-LOW
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 12 affected / 17 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: METABOLIC/LABORATORY - OTHER
Serious: no
Organ System: Investigations
Frequency: 5 affected / 17 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 17 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 17 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 17 at risk

Adverse event: CALCIUM, SERUM-LOW (HYPOCALCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 17 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 17 at risk

Adverse event: GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 17 at risk

Adverse event: GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 17 at risk

Adverse event: MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 17 at risk

Adverse event: PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 17 at risk

Adverse event: POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: POTASSIUM, SERUM-LOW (HYPOKALEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 17 at risk

Adverse event: SODIUM, SERUM-HIGH (HYPERNATREMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 17 at risk

Adverse event: SODIUM, SERUM-LOW (HYPONATREMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 17 at risk

Adverse event: TRIGLYCERIDE, SERUM-HIGH (HYPERTRIGLYCERIDEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 17 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 17 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 / 17 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: 1 affected / 17 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: PAIN - BACK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 17 at risk

Adverse event: PAIN - BONE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 17 at risk

Adverse event: PAIN - EXTREMITY-LIMB
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 17 at risk

Adverse event: PAIN - JOINT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: PAIN - MUSCLE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: PAIN - NECK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: SOFT TISSUE NECROSIS - EXTREMITY-LOWER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 17 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 17 at risk

Adverse event: EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: MOOD ALTERATION - AGITATION
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: MOOD ALTERATION - ANXIETY
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: MOOD ALTERATION - DEPRESSION
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 17 at risk

Adverse event: NEUROLOGY - OTHER
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 17 at risk

Adverse event: PAIN - HEAD/HEADACHE
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 17 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: SYNCOPE (FAINTING)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 17 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 17 at risk

Adverse event: BLADDER SPASMS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 17 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 17 at risk

Adverse event: PAIN - BLADDER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 17 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 17 at risk

Adverse event: RENAL/GENITOURINARY - OTHER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 17 at risk

Adverse event: URINARY FREQUENCY/URGENCY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 17 at risk

Adverse event: IRREGULAR MENSES (CHANGE FROM BASELINE)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 17 at risk

Adverse event: PAIN - PELVIS
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk

Adverse event: PAIN - URETHRA
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 17 at risk

Adverse event: PAIN - VAGINA
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk

Adverse event: VAGINAL DISCHARGE (NON-INFECTIOUS)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 17 at risk

Adverse event: PAIN - THROAT/PHARYNX/LARYNX
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 17 at risk

Adverse event: ADULT RESPIRATORY DISTRESS SYNDROME (ARDS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: BRONCHOSPASM, WHEEZING
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 17 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 17 at risk

Adverse event: EDEMA, LARYNX
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 17 at risk

Adverse event: NASAL CAVITY/PARANASAL SINUS REACTIONS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 17 at risk

Adverse event: PNEUMONITIS/PULMONARY INFILTRATES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - OTHER
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 17 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: 1 affected / 17 at risk

Adverse event: DERMATOLOGY/SKIN - OTHER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 17 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: PAIN - SKIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 17 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 17 at risk

Adverse event: RASH: ACNE/ACNEIFORM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 17 at risk

Adverse event: RASH: DERMATITIS ASSOCIATED WITH RADIATION - RADIATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 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: 2 affected / 17 at risk

Adverse event: RASH: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: SKIN BREAKDOWN/DECUBITUS ULCER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: HEMORRHAGE, GI - ABDOMEN NOS
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 17 at risk

Adverse event: HEMORRHAGE, GI - ANUS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk

Adverse event: HEMORRHAGE, GI - LOWER GI NOS
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 17 at risk

Adverse event: HEMORRHAGE, GI - UPPER GI NOS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk

Adverse event: HEMORRHAGE, GU - BLADDER
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 17 at risk

Adverse event: HEMORRHAGE, GU - URINARY NOS
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 17 at risk

Adverse event: HEMORRHAGE, GU - VAGINA
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 17 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 17 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 17 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 17 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk

Adverse event: VASCULAR - OTHER
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 17 at risk

Adverse event: BLOOD/BONE MARROW - OTHER
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Restrictive cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: LIVER DYSFUNCTION/FAILURE (CLINICAL)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 7 at risk

Adverse event: FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: INFECTION - OTHER
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: ADULT RESPIRATORY DISTRESS SYNDROME (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - OTHER
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: HEMORRHAGE, GU - URINARY NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: BLOOD/BONE MARROW - OTHER
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 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 / 7 at risk

Adverse event: CARDIAC ARRHYTHMIA - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 7 at risk

Adverse event: CARDIAC GENERAL - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 7 at risk

Adverse event: PERICARDIAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 7 at risk

Adverse event: Restrictive cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 7 at risk

Adverse event: VISION-BLURRED VISION
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: VISION-FLASHING LIGHTS/FLOATERS
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: WATERY EYE (EPIPHORA, TEARING)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

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

Adverse event: DISTENSION/BLOATING, ABDOMINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: DYSPHAGIA (DIFFICULTY SWALLOWING)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: INCONTINENCE, ANAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 7 at risk

Adverse event: MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 7 at risk

Adverse event: PAIN - ABDOMEN NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: PAIN - ANUS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 7 at risk

Adverse event: EDEMA: HEAD AND NECK
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: General disorders
Frequency: 4 affected / 7 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 7 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: 4 affected / 7 at risk

Adverse event: PAIN - BUTTOCK
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: PAIN - CHEST WALL
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: PAIN - OTHER
Serious: no
Organ System: General disorders
Frequency: 3 affected / 7 at risk

Adverse event: RIGORS/CHILLS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: SWEATING (DIAPHORESIS)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: LIVER DYSFUNCTION/FAILURE (CLINICAL)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 7 at risk

Adverse event: ALLERGY/IMMUNOLOGY - OTHER
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 7 at risk

Adverse event: FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 7 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 7 at risk

Adverse event: INFECTION - OTHER
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 7 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - BLOOD
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - COLON
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - CONJUNCTIVA
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 7 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - SINUS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - SOFT TISSUE NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 7 at risk

Adverse event: ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 7 at risk

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 7 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 5 affected / 7 at risk

Adverse event: METABOLIC/LABORATORY - OTHER
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Investigations
Frequency: 2 affected / 7 at risk

Adverse event: PROLONGED QTC INTERVAL
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 7 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 7 at risk

Adverse event: CALCIUM, SERUM-LOW (HYPOCALCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 7 at risk

Adverse event: GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 7 at risk

Adverse event: MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 7 at risk

Adverse event: PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 7 at risk

Adverse event: POTASSIUM, SERUM-LOW (HYPOKALEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 7 at risk

Adverse event: SODIUM, SERUM-LOW (HYPONATREMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 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 / 7 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: PAIN - BACK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: PAIN - EXTREMITY-LIMB
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: PAIN - JOINT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: PAIN - MUSCLE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: PAIN - NECK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 7 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 7 at risk

Adverse event: MOOD ALTERATION - ANXIETY
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: MOOD ALTERATION - DEPRESSION
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: NEUROPATHY: MOTOR
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: PAIN - HEAD/HEADACHE
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 7 at risk

Adverse event: PAIN - NEURALGIA/PERIPHERAL NERVE
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 7 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 7 at risk

Adverse event: PSYCHOSIS (HALLUCINATIONS/DELUSIONS)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: BLADDER SPASMS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 7 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: INCONTINENCE, URINARY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: PAIN - BLADDER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: RENAL/GENITOURINARY - OTHER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: URINARY FREQUENCY/URGENCY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: URINE COLOR CHANGE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: PAIN - THROAT/PHARYNX/LARYNX
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: ADULT RESPIRATORY DISTRESS SYNDROME (ARDS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: BRONCHOSPASM, WHEEZING
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 7 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 7 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - OTHER
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 7 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: 1 affected / 7 at risk

Adverse event: DERMATOLOGY/SKIN - OTHER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 7 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 / 7 at risk

Adverse event: SKIN BREAKDOWN/DECUBITUS ULCER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: HEMORRHAGE, GI - ABDOMEN NOS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: HEMORRHAGE, GI - LOWER GI NOS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: HEMORRHAGE, GI - UPPER GI NOS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: HEMORRHAGE, GU - BLADDER
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: HEMORRHAGE, GU - URINARY NOS
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 7 at risk

Adverse event: HEMORRHAGE, GU - VAGINA
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 7 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - BRONCHOPULMONARY NOS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: HEMORRHAGE/BLEEDING - OTHER
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 7 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 7 at risk

Adverse event: HEPATOBILIARY/PANCREAS - OTHER
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: CARDIAC ARRHYTHMIA - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: AUDITORY/EAR - OTHER
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 4 at risk

Adverse event: ASCITES (NON-MALIGNANT)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4 at risk

Adverse event: DISTENSION/BLOATING, ABDOMINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ESOPHAGUS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4 at risk

Adverse event: PAIN - ABDOMEN NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: PAIN - DENTAL/TEETH/PERIDONTAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: EDEMA: HEAD AND NECK
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: EDEMA: TRUNK/GENITAL
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 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: 2 affected / 4 at risk

Adverse event: PAIN - OTHER
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 4 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 4 at risk

Adverse event: INFECTION - OTHER
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 4 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - BLADDER (URINARY)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 4 at risk

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 4 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 3 affected / 4 at risk

Adverse event: Haptoglobin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: METABOLIC/LABORATORY - OTHER
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 4 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4 at risk

Adverse event: CALCIUM, SERUM-LOW (HYPOCALCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 4 at risk

Adverse event: GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 4 at risk

Adverse event: GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4 at risk

Adverse event: PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 4 at risk

Adverse event: POTASSIUM, SERUM-LOW (HYPOKALEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: PAIN - BACK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: PAIN - EXTREMITY-LIMB
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: PAIN - NECK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4 at risk

Adverse event: MOOD ALTERATION - AGITATION
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4 at risk

Adverse event: PAIN - HEAD/HEADACHE
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4 at risk

Adverse event: BLADDER SPASMS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: PAIN - BLADDER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 4 at risk

Adverse event: PAIN - URETHRA
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4 at risk

Adverse event: ADULT RESPIRATORY DISTRESS SYNDROME (ARDS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 4 at risk

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

Adverse event: NASAL CAVITY/PARANASAL SINUS REACTIONS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - OTHER
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: DERMATOLOGY/SKIN - OTHER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: PAIN - SKIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: RASH: ACNE/ACNEIFORM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: HEMORRHAGE, GI - LOWER GI NOS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: HEMORRHAGE, GU - URINARY NOS
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 4 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 4 at risk

Adverse event: VASCULAR - OTHER
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

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

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

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

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

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

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

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: EDEMA: HEAD AND NECK
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

Adverse event: INFECTION - OTHER
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

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

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

Adverse event: CARDIAC TROPONIN I (CTNI)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: PAIN - HEAD/HEADACHE
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1 at risk

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

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

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

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

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: HEMORRHAGE, CNS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1 at risk

Adverse event: Peripheral ischaemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1 at risk