Study: NCT00718809

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Unexpected Change in HEMOGLOBIN level
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: CNS CEREBROVASCULAR ISCHEMIA
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: VESSEL INJURY-VEIN - SVC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: BLOOD/BONE MARROW
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 12 at risk

Adverse event: Myocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: OCULAR/VISUAL
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: VISION-BLURRED VISION
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 12 at risk

Adverse event: GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 12 at risk

Adverse event: MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 12 at risk

Adverse event: PAIN - ABDOMEN NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 12 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 12 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS - OTHER
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: EDEMA: HEAD AND NECK
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 12 at risk

Adverse event: FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 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: 1 affected / 12 at risk

Adverse event: PAIN - CHEST/THORAX NOS
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: RIGORS/CHILLS
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: SWEATING (DIAPHORESIS)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: INFECTION - OTHER
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 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 / 12 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 / 12 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 / 12 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - ORAL CAVITY-GUMS (GINGIVITIS)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 12 at risk

Adverse event: ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 12 at risk

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 12 at risk

Adverse event: BICARBONATE, SERUM-LOW
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 3 affected / 12 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) - TRACHEA
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 12 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 12 at risk

Adverse event: CALCIUM, SERUM-LOW (HYPOCALCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 12 at risk

Adverse event: POTASSIUM, SERUM-LOW (HYPOKALEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 12 at risk

Adverse event: SODIUM, SERUM-LOW (HYPONATREMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 12 at risk

Adverse event: PAIN - BACK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 12 at risk

Adverse event: PAIN - EXTREMITY-LIMB
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: PAIN - JOINT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: PAIN - MUSCLE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 12 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: PAIN - HEAD/HEADACHE
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 12 at risk

Adverse event: MOOD ALTERATION - ANXIETY
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk

Adverse event: MOOD ALTERATION - DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: PAIN - URETHRA
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 12 at risk

Adverse event: RENAL/GENITOURINARY - OTHER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: PAIN - BREAST
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 12 at risk

Adverse event: PAIN - VAGINA
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 12 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - RESPIRATORY TRACT NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: BRONCHOSPASM, WHEEZING
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 12 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 12 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - LUNG
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: NASAL CAVITY/PARANASAL SINUS REACTIONS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: PAIN - SINUS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - OTHER
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 12 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 / 12 at risk

Adverse event: HAIR LOSS/ALOPECIA (SCALP OR BODY)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 12 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: RASH: ACNE/ACNEIFORM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 12 at risk

Adverse event: SWEATING (DIAPHORESIS)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: ASCITES (NON-MALIGNANT)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: DISTENSION/BLOATING, ABDOMINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: DYSPHAGIA (DIFFICULTY SWALLOWING)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: HEMORRHAGE, GI - ANUS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: PAIN - ABDOMEN NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS - OTHER
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 9 at risk

Adverse event: FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 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: 1 affected / 9 at risk

Adverse event: PAIN - CHEST/THORAX NOS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: PAIN - OTHER
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 9 at risk

Adverse event: ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 9 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 9 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 9 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: POTASSIUM, SERUM-LOW (HYPOKALEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: SODIUM, SERUM-LOW (HYPONATREMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN - BACK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN - EXTREMITY-LIMB
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: PAIN - MUSCLE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN - HEAD/HEADACHE
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: SYNCOPE (FAINTING)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: MENTAL STATUS
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 9 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9 at risk

Adverse event: ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 9 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: PNEUMONITIS/PULMONARY INFILTRATES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: HAIR LOSS/ALOPECIA (SCALP OR BODY)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk