Study: NCT00706641

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: FISTULA, GI / ANUS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEMORRHAGE, GI / PERITONEAL CAVITY
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: LEAK (INCLUDING ANASTOMOTIC), GI / SMALL BOWEL
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FLUTTER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: WOUND COMPLICATION, NON-INFECTIOUS
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 25 at risk

Adverse event: ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 25 at risk

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: ATAXIA (INCOORDINATION)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: BICARBONATE, SERUM-LOW
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: BLADDER SPASMS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 25 at risk

Adverse event: CALCIUM, SERUM-LOW (HYPOCALCEMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: CARDIAC GENERAL - OTHER (SPECIFY, __)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 25 at risk

Adverse event: DISTENSION/BLOATING, ABDOMINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 22 affected / 25 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 / 25 at risk

Adverse event: FISTULA, GI / SMALL BOWEL NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: GASTROINTESTINAL - OTHER (SPECIFY, __)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 25 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 25 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 25 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 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 / 25 at risk

Adverse event: HEMORRHAGE, GU / BLADDER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: HEMORRHAGE, GU / URINARY NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 25 at risk

Adverse event: HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEMORRHAGE/BLEEDING ASSOCIATED WITH SURGERY, INTRA-OPERATIVE OR POSTOPERATIVE
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 25 at risk

Adverse event: INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / BLADDER (URINARY)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 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 / 25 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 / 25 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / PERITONEAL CAVITY
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: INFECTION WITH UNKNOWN ANC / VAGINA
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY - OTHER (SPECIFY, __)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: MOOD ALTERATION / ANXIETY
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 25 at risk

Adverse event: MOOD ALTERATION / DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 25 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 25 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 25 at risk

Adverse event: NEUROLOGY - OTHER (SPECIFY, __)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: OBSTRUCTION, GU / BLADDER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: PAIN / ABDOMEN NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 25 at risk

Adverse event: PAIN / BACK
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: PAIN / BLADDER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 25 at risk

Adverse event: PAIN / BONE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN / BUTTOCK
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN / EXTREMITY-LIMB
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: PAIN / HEAD/HEADACHE
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk

Adverse event: PAIN / JOINT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: PAIN / MUSCLE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN / PAIN NOS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: PAIN / PELVIS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: PAIN / PENIS
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN / RECTUM
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN / STOMACH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN / TESTICLE
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN / THROAT/PHARYNX/LARYNX
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN / TUMOR PAIN
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: PAIN - OTHER (SPECIFY, __)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 25 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: PANCREATIC ENDOCRINE: GLUCOSE INTOLERANCE
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 25 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 25 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: RASH: ACNE/ACNEIFORM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: RASH: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: RENAL/GENITOURINARY - OTHER (SPECIFY, __)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 25 at risk

Adverse event: RIGORS/CHILLS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: SALIVARY GLAND CHANGES/SALIVA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: SKIN BREAKDOWN/DECUBITUS ULCER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: SODIUM, SERUM-LOW (HYPONATREMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS TACHYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: SWEATING (DIAPHORESIS)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 25 at risk

Adverse event: URINARY FREQUENCY/URGENCY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 25 at risk

Adverse event: URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: URINE COLOR CHANGE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: URTICARIA (HIVES, WELTS, WHEALS)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 25 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk