Study: NCT00253435

Adverse event: Blood/Bone Marrow - Other (DELAYED PLATELET ENGRAFTMENT)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Blood/Bone Marrow - Other (INFUSION OF BACKUP STEM CELLS)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 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: 2 affected / 42 at risk

Adverse event: Hepatobiliary/Pancreas - Other (HEPATOMEGALY)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 42 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils (Blood)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 42 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils (Catheter-related)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 42 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 42 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 42 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 42 at risk

Adverse event: Pain (Head/headache)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 42 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Febrile neutropenia (fever of unknown origin)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 31 affected / 42 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 40 affected / 42 at risk

Adverse event: Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Lymphatics - Other (CAPILLARY LEAK)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Lymphatics - Other (GENERALIZED EDEMA)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Cardiac Arrhythmia - Other (MURMUR)
Serious: no
Organ System: Cardiac disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Cardiac Arrhythmia - Other (SINUS TACHYCARDIA)
Serious: no
Organ System: Cardiac disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Cardiac General - Other (SYSTOLIC MURMUR)
Serious: no
Organ System: Cardiac disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Supraventricular and nodal arrhythmia (Atrial tachycardia/Paroxysmal Atrial Tachycardia)
Serious: no
Organ System: Cardiac disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Supraventricular and nodal arrhythmia (Sinus tachycardia)
Serious: no
Organ System: Cardiac disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 11 affected / 42 at risk

Adverse event: Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
Serious: no
Organ System: Ear and labyrinth disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Hearing: patients without baseline audiogram and not enrolled in a monitoring program
Serious: no
Organ System: Ear and labyrinth disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Otitis, middle ear (non-infectious)
Serious: no
Organ System: Ear and labyrinth disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Middle ear)
Serious: no
Organ System: Ear and labyrinth disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Endocrine - Other (TSH)
Serious: no
Organ System: Endocrine disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Thyroid function, high (hyperthyroidism, thyrotoxicosis)
Serious: no
Organ System: Endocrine disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Ocular/Visual - Other (BILATERAL CONJUNCTIVAL HEMORRHAGE)
Serious: no
Organ System: Eye disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Eye)
Serious: no
Organ System: Eye disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Ascites (non-malignant)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 42 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 42 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 42 at risk

Adverse event: Dental: teeth
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 32 affected / 42 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 42 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Gastrointestinal - Other (HICCUPS)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Gastrointestinal - Other (LOOSE TEETH)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Gastrointestinal - Other (REFLUX)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Hemorrhage, GI (Lower GI NOS)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Hemorrhage, GI (Oral cavity)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Hemorrhage, GI (Stomach)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Hemorrhage, GI (Upper GI NOS)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 42 at risk

Adverse event: Mucositis/stomatitis (clinical exam) (Anus)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Mucositis/stomatitis (clinical exam) (Esophagus)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Mucositis/stomatitis (clinical exam) (Oral cavity)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 29 affected / 42 at risk

Adverse event: Mucositis/stomatitis (clinical exam) (Rectum)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) (Large bowel)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) (Oral cavity)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 14 affected / 42 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) (Small bowel)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) (Stomach)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 32 affected / 42 at risk

Adverse event: Obstruction, GI (Small bowel NOS)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Abdomen NOS)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 20 affected / 42 at risk

Adverse event: Pain (Esophagus)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Oral cavity)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 19 affected / 42 at risk

Adverse event: Pain (Oral-gums)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Rectum)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Stomach)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Salivary gland changes/saliva
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Typhlitis (cecal inflammation)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 33 affected / 42 at risk

Adverse event: Constitutional Symptoms - Other (BRITTLE HAIR)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Constitutional Symptoms - Other (RHINORRHEA)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Edema:head and neck
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 42 at risk

Adverse event: Edema:limb
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Edema:trunk/genital
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 12 affected / 42 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
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 16 affected / 42 at risk

Adverse event: Irritability (children <3 years of age)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Chest/thorax NOS)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Pain (Face)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Pain NOS)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain - Other (BROVIAC SITE)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain - Other (CVC SITE)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain - Other (GENERAL (NOS))
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Pain - Other (MOUTH PAIN)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain - Other (MUCOSITIS)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain - Other (PAROTID GLAND)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain - Other (WHOLE BODY)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Hepatobiliary/Pancreas - Other (CHOLANGITIS)
Serious: no
Organ System: Hepatobiliary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: no
Organ System: Hepatobiliary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Liver)
Serious: no
Organ System: Hepatobiliary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Portal vein flow
Serious: no
Organ System: Hepatobiliary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Cytokine release syndrome/acute infusion reaction
Serious: no
Organ System: Immune system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Blood)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 42 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Catheter-related)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Lung (pneumonia))
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Mucosa)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Sinus)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Skin (cellulitis))
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection - Other (ASPERGILLUS OF MOUTH)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection - Other (L-PRESEPTAL CELLULITIS)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection - Other (ORAL CANDIDA)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection - Other (PERIRECTAL CELLULITIS)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection - Other (URINE + FOR CYTOMEGALOVIRUS)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection - Other (VARICELLA)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils (Blood)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 42 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils (Bronchus)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils (Catheter-related)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils (Colon)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils (Lung (pneumonia))
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 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
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils (Sinus)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils (Small bowel NOS)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils (Upper airway NOS)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Infection with unknown ANC (Catheter-related)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Opportunistic infection associated with >=Grade 2 Lymphopenia
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Rash: dermatitis associated with radiation (Chemoradiation)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 34 affected / 42 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 36 affected / 42 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 42 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 10 affected / 42 at risk

Adverse event: Cholesterol, serum-high (hypercholesteremia)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 7 affected / 42 at risk

Adverse event: Blood fibrinogen
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 15 affected / 42 at risk

Adverse event: INR (International Normalized Ratio of prothrombin time)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 7 affected / 42 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 38 affected / 42 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 30 affected / 42 at risk

Adverse event: Metabolic/Laboratory - Other (CHLORIDE)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Metabolic/Laboratory - Other (HYPERCHLORIDEMIA)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Metabolic/Laboratory - Other (HYPERPHOSPHATEMIA)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Metabolic/Laboratory - Other (INCREASED CHLORIDE)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Metabolic/Laboratory - Other (PRE-ALBUMIN)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 39 affected / 42 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 42 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 40 affected / 42 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 10 affected / 42 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 42 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 38 affected / 42 at risk

Adverse event: Alkalosis (metabolic or respiratory)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 25 affected / 42 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 42 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 42 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 29 affected / 42 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 42 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 30 affected / 42 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 16 affected / 42 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 12 affected / 42 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 22 affected / 42 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 26 affected / 42 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 12 affected / 42 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 32 affected / 42 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 9 affected / 42 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 34 affected / 42 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 28 affected / 42 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 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
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity-upper)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other (NOT SPECIFIED)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other (OCCASIONAL ACHES AND PAINS)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Back)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Pain (Bone)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Pain (Chest wall)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Extremity-limb)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 9 affected / 42 at risk

Adverse event: Pain (Joint)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Pain (Neck)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Neurology - Other (ACHY FEELING)
Serious: no
Organ System: Nervous system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Neurology - Other (DYSTONIC REACTION)
Serious: no
Organ System: Nervous system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Neurology - Other (GENERALIZED TENDERNESS)
Serious: no
Organ System: Nervous system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Neuropathy: cranial (CN VII Motor-face; Sensory-taste)
Serious: no
Organ System: Nervous system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Head/headache)
Serious: no
Organ System: Nervous system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 42 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 42 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Mood alteration (Agitation)
Serious: no
Organ System: Psychiatric disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Mood alteration (Anxiety)
Serious: no
Organ System: Psychiatric disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 42 at risk

Adverse event: Mood alteration (Depression)
Serious: no
Organ System: Psychiatric disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: no
Organ System: Psychiatric disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Bladder spasms
Serious: no
Organ System: Renal and urinary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Hemorrhage, GU (Bladder)
Serious: no
Organ System: Renal and urinary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Hemorrhage, GU (Urinary NOS)
Serious: no
Organ System: Renal and urinary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Pain (Bladder)
Serious: no
Organ System: Renal and urinary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 12 affected / 42 at risk

Adverse event: Renal/Genitourinary - Other (DECREASED URINE OUTPUT)
Serious: no
Organ System: Renal and urinary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Renal/Genitourinary - Other (FLUID RETENTION)
Serious: no
Organ System: Renal and urinary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: Renal and urinary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Pain (Pelvis)
Serious: no
Organ System: Reproductive system and breast disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Penis)
Serious: no
Organ System: Reproductive system and breast disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Scrotum)
Serious: no
Organ System: Reproductive system and breast disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 13 affected / 42 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory (Nose)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 18 affected / 42 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory (Respiratory tract NOS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 10 affected / 42 at risk

Adverse event: Mucositis/stomatitis (clinical exam) (Larynx)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Mucositis/stomatitis (clinical exam) (Pharynx)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) (Pharynx)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Larynx)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Throat/pharynx/larynx)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 42 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (CONGESTION)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (HYPERCARBIA)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (RHINORRHEA)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (RUNNY NOSE)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (TACHYPNEIC)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Dermatology/Skin - Other (DRY LIPS)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Dermatology/Skin - Other (FACIAL ABRAISIONS)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Dermatology/Skin - Other (LACERATION)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Dermatology/Skin - Other (PEELING SKIN)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Dermatology/Skin - Other (PERIORBITAL ECCHYMOSES)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Dermatology/Skin - Other (PSEUDOMEMBRANOUS CHANGES)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Dermatology/Skin - Other (SORE/SCAB)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Dermatology/Skin - Other (SUN BURN)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Dermatology/Skin - Other (ZOSTER LESION)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 42 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 42 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 42 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 42 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 19 affected / 42 at risk

Adverse event: Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 42 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Hemorrhage/Bleeding - Other (EPISTAXIS)
Serious: no
Organ System: Vascular disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 42 at risk

Adverse event: Hemorrhage/Bleeding - Other (EYE)
Serious: no
Organ System: Vascular disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Hemorrhage/Bleeding - Other (HEMATURIA)
Serious: no
Organ System: Vascular disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Hemorrhage/Bleeding - Other (HEMOPTYSIS)
Serious: no
Organ System: Vascular disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Hemorrhage/Bleeding - Other (NOSE BLEED)
Serious: no
Organ System: Vascular disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Hemorrhage/Bleeding - Other (TONGUE BLEED)
Serious: no
Organ System: Vascular disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 42 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 42 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 13 affected / 42 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils (Catheter-related)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Blood/Bone Marrow - Other (DELAYED ENGRAFTMENT ANC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Blood/Bone Marrow - Other (INFUSION OF BACKUP SC FOR DELAYED ENGRAFTMENT)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Febrile neutropenia (fever of unknown origin)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 8 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 7 affected / 8 at risk

Adverse event: Ventricular arrhythmia (Ventricular arrhythmia NOS)
Serious: no
Organ System: Cardiac disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
Serious: no
Organ System: Ear and labyrinth disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 8 at risk

Adverse event: Hemorrhage, GI (Oral cavity)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Mucositis/stomatitis (clinical exam) (Oral cavity)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 8 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) (Oral cavity)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 8 at risk

Adverse event: Pain (Abdomen NOS)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 8 at risk

Adverse event: Pain (Esophagus)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Pain (Oral cavity)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 8 at risk

Adverse event: Pain (Rectum)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Pain (Stomach)
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 7 affected / 8 at risk

Adverse event: Edema:head and neck
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 8 at risk

Adverse event: Edema:trunk/genital
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 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
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 8 at risk

Adverse event: Pain - Other (OROPHANRIX)
Serious: no
Organ System: General disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Blood)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 8 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Catheter-related)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Skin (cellulitis))
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils (Blood)
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Infection with unknown ANC (Skin (cellulitis))
Serious: no
Organ System: Infections and infestations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 8 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 8 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 8 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: INR (International Normalized Ratio of prothrombin time)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 8 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 8 at risk

Adverse event: Metabolic/Laboratory - Other (DECREASED TOTAL PROTEIN)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Metabolic/Laboratory - Other (HYPERCHLOREMIA)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Metabolic/Laboratory - Other (INCREASED FIBRINOGEN)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 7 affected / 8 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 7 affected / 8 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 8 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 8 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 8 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 8 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 8 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 8 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 8 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 7 affected / 8 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 8 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 8 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 8 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
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Mood alteration (Anxiety)
Serious: no
Organ System: Psychiatric disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: no
Organ System: Psychiatric disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 8 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Pain (Penis)
Serious: no
Organ System: Reproductive system and breast disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 8 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Mucositis/stomatitis (clinical exam) (Pharynx)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) (Pharynx)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Pain (Throat/pharynx/larynx)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 8 at risk

Adverse event: Dermatology/Skin - Other (INGROWN TOENAIL)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 8 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Hemorrhage/Bleeding - Other (HEMATURIA)
Serious: no
Organ System: Vascular disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 8 at risk