Study: NCT00477386

Adverse event: OBSTRUCTION, GI - SMALL BOWEL NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 11 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 / 11 at risk

Adverse event: PAIN - HEAD/HEADACHE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: PAIN - STOMACH
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: LEAK (INCLUDING ANASTOMOTIC), GI - SMALL BOWEL
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: OBSTRUCTION, GI - DUODENUM
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: DISTENSION/BLOATING, ABDOMINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: GASTROINTESTINAL - OTHER (SPECIFY, __)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 11 at risk

Adverse event: OBSTRUCTION, GI - SMALL BOWEL NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 11 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 11 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 / 11 at risk

Adverse event: PAIN - ABDOMEN NOS
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: PAIN - BACK
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: PAIN - BONE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: PAIN - EXTREMITY-LIMB
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: PAIN - HEAD/HEADACHE
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 11 at risk

Adverse event: INFECTION - OTHER (SPECIFY, __)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 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 / 11 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 11 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: MOOD ALTERATION - ANXIETY
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: HEMORRHAGE, GU - URINARY NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: LEAK (INCLUDING ANASTOMOTIC), GU - VAGINA
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 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 / 11 at risk

Adverse event: HAIR LOSS/ALOPECIA (SCALP OR BODY)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

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

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

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 17 at risk

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

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

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 17 at risk

Adverse event: LYMPHATICS - OTHER (SPECIFY, __)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 at risk

Adverse event: PERICARDIAL EFFUSION (NON-MALIGNANT)
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: ENDOCRINE - OTHER (SPECIFY, __)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 17 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 17 at risk

Adverse event: DISTENSION/BLOATING, ABDOMINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: GASTROINTESTINAL - OTHER (SPECIFY, __)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 17 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 17 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

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

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 17 at risk

Adverse event: FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
Serious: no
Organ System: General disorders
Frequency: 1 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: 3 affected / 17 at risk

Adverse event: PAIN - ABDOMEN NOS
Serious: no
Organ System: General disorders
Frequency: 7 affected / 17 at risk

Adverse event: PAIN - BACK
Serious: no
Organ System: General disorders
Frequency: 4 affected / 17 at risk

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

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

Adverse event: PAIN - EXTERNAL EAR
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

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

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

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

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

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

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

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

Adverse event: ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
Serious: no
Organ System: Immune system disorders
Frequency: 8 affected / 17 at risk

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

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

Adverse event: INFECTION WITH UNKNOWN ANC - NOSE
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: 3 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: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 5 affected / 17 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 17 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Investigations
Frequency: 4 affected / 17 at risk

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

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 17 at risk

Adverse event: MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 17 at risk

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

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

Adverse event: JOINT-EFFUSION
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: JOINT-FUNCTION
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 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 (SPECIFY, __)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

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

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

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

Adverse event: NEUROPATHY: CRANIAL - CN V MOTOR-JAW MUSCLES; SENSORY-FACIAL
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

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

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

Adverse event: SPEECH IMPAIRMENT (E.G., DYSPHASIA OR APHASIA)
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: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 17 at risk

Adverse event: MOOD ALTERATION - DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: PSYCHOSIS (HALLUCINATIONS/DELUSIONS)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

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

Adverse event: RENAL/GENITOURINARY - OTHER (SPECIFY, __)
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: 1 affected / 17 at risk

Adverse event: HOT FLASHES/FLUSHES
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: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 17 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: NASAL CAVITY/PARANASAL SINUS REACTIONS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 17 at risk

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

Adverse event: HAIR LOSS/ALOPECIA (SCALP OR BODY)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

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

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 17 at risk

Adverse event: RASH: ACNE/ACNEIFORM
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: SWEATING (DIAPHORESIS)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

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

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

Adverse event: PHLEBITIS (INCLUDING SUPERFICIAL THROMBOSIS)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk

Adverse event: VASCULAR - OTHER (SPECIFY, __)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk