Study: NCT00130520

Adverse event: Hospitalization for dyspnea and fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: hospitalization for diarrhea, nausea, vomiting and facial rash (CTCAE grade 2)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hospitalization for partial bowel obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hospitalizaton for diarrhea, abdomianl bloating, dyspnea
Serious: yes
Organ System: General disorders
Notes: Diagnosed as right pleural effusion
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death was due to disease progression and not study related
Frequency: 1 affected / 40 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Bowel perforation-large intestine
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Possible Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: This MI was never confirmed and the investigator does not believe it was actually and MI
Frequency: 1 affected / 40 at risk

Adverse event: Abdominal fistula
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nasal septal perforation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hospitalization for intercranial bleed
Serious: yes
Organ System: General disorders
Notes: This was never able to be confirmed
Frequency: 1 affected / 40 at risk

Adverse event: Hospitalization for fever
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hospitilization for skin rash and pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hospitilization for weakness and low hemoglobin
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hospitalization for fatigue, dyspnea, weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hospitalization for headache and parasthesis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 40 at risk

Adverse event: Allergy/Immunology-Other
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hemoglobin values out of normal range
Frequency: 5 affected / 40 at risk

Adverse event: Neutrophils/granuloctyes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Neutrophils/granulocytes out of normal range
Frequency: 4 affected / 40 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelet count out of normal range
Frequency: 2 affected / 40 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 40 at risk

Adverse event: Constitutional Symptoms (Other)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 40 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 10 affected / 40 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 40 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: no
Organ System: General disorders
Notes: Neutropenia is defined as ANC\<1.0x10e9/L
Frequency: 3 affected / 40 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 40 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Pruritius/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 40 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 40 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 40 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 40 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 40 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 40 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 40 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Dysphagia (difficulty swllowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Gastrointestinal-Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 40 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 40 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Mucositis/stomatitis (clincal exam)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 40 at risk

Adverse event: Taste alteration dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 40 at risk

Adverse event: Hemorrhage, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 40 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Hemorrhage/Bleeding-Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 40 at risk

Adverse event: Infection (documented clinically or microbiologically)
Serious: no
Organ System: Infections and infestations
Notes: with Grade 3 or 4 neutrophils (ANC\<1.0x10e)
Frequency: 5 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 40 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 40 at risk

Adverse event: Edema:limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Lymphatics-Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 40 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 40 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Out of normal laboratory range
Frequency: 6 affected / 40 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Outside of normal laboratory range
Frequency: 6 affected / 40 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 40 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 40 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 40 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 40 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 40 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 40 at risk

Adverse event: Musculoskeletal/Soft Tissue-Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 40 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 40 at risk

Adverse event: Mood Alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 40 at risk

Adverse event: Neuropathy: cranial or sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 40 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 40 at risk

Adverse event: Ocular/Visual-Other
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 40 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 40 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 40 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 40 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 40 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: 8 affected / 40 at risk

Adverse event: Renal/Genitourinary-other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 40 at risk

Adverse event: Urinary Frequency/Urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vascular-Other
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 40 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 9 affected / 40 at risk

Adverse event: Pulmonary/Upper Respiratory-Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 40 at risk