Study: NCT01031381

Adverse event: Cardiac General - Other (Specify, __)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Distension/bloating, abdominal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Fistula, GI, Colon/cecum/appendix
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Mucositis/stomatitis (clinical exam), Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Obstruction, GI, Ileum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Obstruction, GI, Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Hemorrhage, GU, Bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Infection with unknown ANC, Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Infection with unknown ANC, Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy), Left-sided
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Neurology - Other (Specify, __)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Speech impairment (e.g., dysphasia or aphasia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain, Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 50 at risk

Adverse event: Pain, Rectum
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Bronchospasm, wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, __)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 50 at risk

Adverse event: Blood/Bone Marrow - Other (Specify, __)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 50 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 50 at risk

Adverse event: Supraventricular and nodal arrhythmia, Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Supraventricular and nodal arrhythmia, Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cardiac Arrhythmia - Other (Specify, __)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 50 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 50 at risk

Adverse event: Supraventricular and nodal arrhythmia, Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 50 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 50 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 50 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 50 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 / 50 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Constitutional Symptoms - Other (Specify, __)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 50 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 8 affected / 50 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 30 affected / 50 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Rash: dermatitis associated with radiation, Chemoradiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 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 / 50 at risk

Adverse event: Urticaria (hives, welts, wheals)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Wound complication, non-infectious
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 50 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 50 at risk

Adverse event: Dermatology/Skin - Other (Specify, __)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 50 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Fistula, GI, Colon/cecum/appendix
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Mucositis/stomatitis (clinical exam), Larynx
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Ascites (non-malignant)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Mucositis/stomatitis (clinical exam), Anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Mucositis/stomatitis (clinical exam), Rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 50 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 50 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 50 at risk

Adverse event: Gastrointestinal - Other (Specify, __)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 50 at risk

Adverse event: Dental: teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 50 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 50 at risk

Adverse event: Mucositis/stomatitis (clinical exam), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 50 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hemorrhage, GI, Anus
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 50 at risk

Adverse event: Hemorrhage/Bleeding - Other (Specify, __)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 50 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory, Nose
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 50 at risk

Adverse event: Infection - Other (Specify, __)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Infection (documented) Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 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 / 50 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Soft tissue NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 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 / 50 at risk

Adverse event: Infection with unknown ANC, Larynx
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Infection with unknown ANC, Oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Infection with unknown ANC, Pelvis NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Infection with unknown ANC, Bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Infection with unknown ANC, Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Infection with unknown ANC, Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Infection with unknown ANC, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Infection with unknown ANC, Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 50 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Lymphatics - Other (Specify, __)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 50 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 2 affected / 50 at risk

Adverse event: Metabolic/Laboratory - Other (Specify, __)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 50 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 50 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 50 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 50 at risk

Adverse event: Cholesterol, serum-high (hypercholesteremia)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 50 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 50 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 50 at risk

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 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 / 50 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: 5 affected / 50 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other (Specify, __)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 50 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Mood alteration, Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Neurology - Other (Specify, __)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 50 at risk

Adverse event: Mood alteration, Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 50 at risk

Adverse event: Ocular/Visual - Other (Specify, __)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain, Anus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain, Dental/teeth/peridontal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain, Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain, Neuralgia/peripheral nerve
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain, Pelvis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain, Rectum
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain, Stomach
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain, Urethra
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain, Vagina
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain, Bone
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Pain, Joint
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Pain, Back
Serious: no
Organ System: General disorders
Frequency: 4 affected / 50 at risk

Adverse event: Pain, Throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 4 affected / 50 at risk

Adverse event: Pain, Muscle
Serious: no
Organ System: General disorders
Frequency: 6 affected / 50 at risk

Adverse event: Pain, Pain NOS
Serious: no
Organ System: General disorders
Frequency: 6 affected / 50 at risk

Adverse event: Pain - Other (Specify, __)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 50 at risk

Adverse event: Pain, Head/headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 50 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 21 affected / 50 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 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: 2 affected / 50 at risk

Adverse event: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, __)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 50 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 50 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 50 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Fistula, GU, Ureter
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Obstruction, GU, Ureter
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Bladder spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 50 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 50 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 50 at risk

Adverse event: Renal/Genitourinary - Other (Specify, __)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 50 at risk

Adverse event: Vaginal discharge (non-infectious)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 50 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 6 affected / 50 at risk

Adverse event: Phlebitis (including superficial thrombosis)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Vascular - Other (Specify, __)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk