Study: NCT00043979

Adverse event: Cardiac General: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Constitutional Symptoms: Fever
Serious: yes
Organ System: General disorders
Notes: (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)
Frequency: 1 affected / 30 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Death: Death not associated with CTCAE term: Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 29 affected / 30 at risk

Adverse event: Gastrointestinal: Diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal:Mucositis/stomatitis (clinical exam)::oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: GI, other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Infection with neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: (fever of unknown origin without clinically or microbiologically documented infection) (ANC \<1.0x10e9/L, fever \>=38.5 degrees C)
Frequency: 1 affected / 30 at risk

Adverse event: Intussception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Bilirubin, serum-high (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Metabolic/Laboratory: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Metabolic/Laboratory: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mood alteration; suicide gesture
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neurology: Mood alteration: anxiety
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neurology: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain - right chest wall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary - Other (pulmonary edema w/normal 02 sat)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Radiation Recall Reaction (anterior chest)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Vaginal infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: AST, high
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pneumonitits/Pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Abscesses (crypt)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Acne breakout
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Agitated mental status
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Alk. phosph.
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Allergic rhinitis-rhinorrhea
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Allergy/Immunology: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Allergy/Immunology: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 18 affected / 30 at risk

Adverse event: Allergy/Immunology: Autoimmune reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Appetite decreased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Bilious emesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood/Bone Marrow:Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 30 at risk

Adverse event: Blood/Bone Marrow:Hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 30 at risk

Adverse event: Blood/Bone Marrow:Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 30 at risk

Adverse event: Blood/Bone Marrow:Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 30 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 30 at risk

Adverse event: Myringitis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Burns, radiation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac Arrhythmia: Supraventricular and nodal arrhythmia - Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 30 at risk

Adverse event: Cardiac General: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 30 at risk

Adverse event: Cardiac General:Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 30 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Compression of vena cava by tumor
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Congestion
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Constitutional Symptoms - Other (pallor)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Constitutional Symptoms: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 20 affected / 30 at risk

Adverse event: Constitutional Symptoms: Fever
Serious: no
Organ System: General disorders
Notes: (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)
Frequency: 20 affected / 30 at risk

Adverse event: Constitutional Symptoms: Insomnia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 30 at risk

Adverse event: Constitutional Symptoms: Weight loss
Serious: no
Organ System: General disorders
Frequency: 6 affected / 30 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 30 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Dermatology/Skin: Pigmentation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Dermatology/Skin: Dermatology/Skin-Other (lip abrasion)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Dermatology/Skin-Other (specify: verrucae)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 30 at risk

Adverse event: Dermatology/Skin: Rash/dermatitis associated with high dose chemotherapy or BMT studies
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Rash: acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 30 at risk

Adverse event: Dermatology/Skin: Dermatology/Skin-Other (specify, keratosis pilaris)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Dermatology/Skin: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Dermatology/Skin: Nail changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Dermatology/Skin: Photosensitivity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 30 at risk

Adverse event: Dermatology/Skin: Rash/desquamation associated with graft versus host disease (GVHD)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: for BMT studies, if specified in the protocol
Frequency: 5 affected / 30 at risk

Adverse event: Dermatology/Skin: Rash: dermatitis associated with radiation-select: radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Striae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Desquamation of palmar surface of hands, B/L
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Desquamation, vaginal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Dystonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 30 at risk

Adverse event: Ears-dry
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Edema, extremities
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Endocrine: Cushingoid appearance
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 30 at risk

Adverse event: Epidermal abrasions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Erythema, palms of hands
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Erythema - abdominal incision
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Erythema - buccal mucosa
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Erythema-face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Erythema - right great toe pus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Erythemateous patchy rash - mild, primarily involving trunk but listed (back, chest, arms)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Esophagitis, chronic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Eyes - dry bilateral
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary fibrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fissure
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Flat effect
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal: Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 30 at risk

Adverse event: Gastrointestinal:Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 30 at risk

Adverse event: Gastrointestinal:Dental: periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal:Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 30 at risk

Adverse event: Gastrointestinal:Distention, bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal:Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal:Heartburn/Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Gastrointestinal:Hemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal:Mucositis/stomatitis (clinical exam)::oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 30 at risk

Adverse event: Gastrointestinal:Mucositis/stomatitis (functional/symptomatic)::pharynx
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal:Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 30 at risk

Adverse event: Graft versus host disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: GVHD, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: GVHD - cutaneous
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: GVHD, GI & skin & liver
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: GVHD, liver
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: GVHD: skin, liver, oral and vaginal mucosa
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: GVHD - skin, liver, oral buccal mucosa
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hallucination(s)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Headaches-intermittent
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hemorrhage, epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding: Hemorrhage, pulmonary/upper respiratory-select
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: hemorrhage, pulmonary/upper respiratory - pleura
Frequency: 1 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding: Vagina
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hepatic: Bilirubin associated with graft versus host disease (GVHD) for BMT studies,
Serious: no
Organ System: Hepatobiliary disorders
Notes: if specified in the protocol
Frequency: 4 affected / 30 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hypoxia-Hypoxemic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Increased cavitary nodular infiltrate in left lower lobe
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection-Other
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Infection-Other (specify) tinea pedis, left foot
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection - sexual/reproductive function - vulva
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection w/neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 30 at risk

Adverse event: Infection, C. diff & rota virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection, CVL
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection, influenza (w/o neutropenia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection, musculo-skeletal, soft tissue
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: (fever of unknown origin without clinically or microbiologically documented infection) (ANC \<1.0x10e9/L, fever \>=38.5 degrees C)
Frequency: 5 affected / 30 at risk

Adverse event: Infection: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC\<1.0x10e9/L): pulmonary/upper respiratory - lung (pneumonia)
Frequency: 5 affected / 30 at risk

Adverse event: Infection: Infection (documented clinically or microbiologically)
Serious: no
Organ System: Infections and infestations
Notes: with Grade 3 or 4 neutrophils (ANC\<1.0x10e9/L): skin (cellulites)
Frequency: 4 affected / 30 at risk

Adverse event: Infection: Infection with normal ANC or Grade 1 or 2 neutrophils:
Serious: no
Organ System: Infections and infestations
Notes: pulmonary/upper respiratory, upper airway NOS
Frequency: 1 affected / 30 at risk

Adverse event: Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: select - conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 30 at risk

Adverse event: Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: skin
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection-upper respiratory symptoms
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infiltrate (lung)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Itching (anal warts)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Joint soreness, intermittent
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Joint stiffness & pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Low energy level
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Lymphatics: edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 30 at risk

Adverse event: Lymphocyte count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Macular rash on anterior and posterior chest
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Bilirubin, serum-high (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Other (Urea nitrogen, low???)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Cholesterol, serum high (hypercholestremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 30 at risk

Adverse event: Metabolic/Laboratory: AST, SGOT (serum glutamic oxaloacetic)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 30 at risk

Adverse event: Mg, low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 30 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mild constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mild cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mild nasal congestion
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mild neuropathy of right foot
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mild tenderness in lumbosacral area
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Molluscum rash to upper thighs B/L
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Mood alteration-depression
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Muscle aches-back, hip, left neck, right lateral chest wall, right scapular
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/other-joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft tissue: joint-effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft tissue: Muscle weakness, genralized or specific area
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: (not due to neuropathy) - select- extremity-lower
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft tissue: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Musculoskeletal/Soft tissue: Muscle weakness, generalized or specific area (not due to neuropathy):
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Extremity-lower
Frequency: 2 affected / 30 at risk

Adverse event: Musculoskeletal/Soft tissue: Musculoskeletal/Soft tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: (specify, radiation changes to pelvis)
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft tissue: Osteonecrosis (avascular necrosis)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Myalgia-Muscle cramps
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Myalgias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neurology: Mood alteration: agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Neurology: mood alteration: anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 30 at risk

Adverse event: Neurology: mood alteration: depression
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 30 at risk

Adverse event: Neurology: neuropathy: cranial - select neuropathy: CN XII motor- tongue
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neurology: neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 30 at risk

Adverse event: Neurology: seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Neurology: tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 30 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ocular/Visual: dry eye syndrome
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Ocular/Visual: cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ocular/Visual: Ocular/Visual - Other (specify, erythema)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ocular/Visual: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Oral pain, esophageal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Other, edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Other, fluid overload
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Other, sixth nerve palsy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pain, head
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain mouth sore
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain perianal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain thoracic
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 30 at risk

Adverse event: Pain, chest
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain, extremities (throbbing)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain, Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pain, knee
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain, left trapezius and shoulder area
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain, myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pain, oral mucosa
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain, ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain, musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain, tenderness (chest)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: pain/auditory/ear: external
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Coagulation: PTT (partial thromboplastin time)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 30 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain/Gastrointestinal:dental/teeth/periodontal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain/Musculoskeletal:Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 30 at risk

Adverse event: Pain/Musculoskeletal:Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 30 at risk

Adverse event: Pain/Musculoskeletal:Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pain/Musculoskeletal:Buttock
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain/Musculoskeletal:Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pain/Neurology:Head/Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 30 at risk

Adverse event: Pain/Ocular: eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain/Pulmonary/Upper Respiratory: Chest/thorax NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain/Pulmonary/Upper Respiratory:Chest wall
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Pain/Pulmonary/Upper Respiratory:Pleura
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain/Pulmonary/Upper Respiratory:Sinus
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain:Chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain: pleuritic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain:vaginally
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain:Gastrointestinal: oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Papular rash hands
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Paronychia, hallux, B/L
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Peeling-bilateral palms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pericardial fluid
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Poor appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Positive viral culture
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: PT, prolonged
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 30 at risk

Adverse event: RBC transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Respiratory, other, tachypnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Transfusion, platelet
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Ulcer, duodenal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ulcers near molars
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Uveitis, OU
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vertigo (sensation)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Visual hallucination
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 30 at risk

Adverse event: Xeropthalmia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: Dermatology-Skin
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 30 at risk

Adverse event: Pain: Musculoskeletal - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 30 at risk

Adverse event: Pain: NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain: Pain: Auditory/Ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain-ankles & knees
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Pain - chest
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pain - left eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - right eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - scapular
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - skull
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Palmar erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Patchy erythema, upper and lower extremities, palms and soles, B/L
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Phosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pigmentation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Post-nasal drainage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Protein low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pulmonary emboli
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory: Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory: Hypoxemia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Radiation Dermatits
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Rash - erythematous, mild, lacy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash - trunk, arms, face, legs, sparing feet
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash (Acne)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash (maculopapular) GVHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash (port erythema)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash, B/L LEs and UEs
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash, erythematous (GVHD)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash, palmar surface
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash, erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash - chest & palms of hands
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash - soles
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Right hip - slightly limited range of motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sacro-iliac pain, right side
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sensitive teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Severe fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Skin fibrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Skin lesions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 30 at risk

Adverse event: Stomatitis, candida
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 30 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Tearing
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Tenderness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Thrombophlebitis, superficial, B/L
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Total bilirubin, high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 30 at risk

Adverse event: Transfusion, RBC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Ulceration on right buccal mucosa
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vulvovaginal discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vascular: thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Visual changes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Allergy/Immunology: Allergic rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Ankle edema B/L
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ankle swelling, bilaterally
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Auditory/Ear: Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Auditory/Hearing: External auditory canal
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood/Bone Marrow:CD4 Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood/Bone Marrow:Haptoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: BMT Complex/Multicomponent Events: Graft versus host disease
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Body aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: C. difficile colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac Arrhythmia - Prolonged QTc interval
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Cardiac Arrhythmia: Supraventricular and nodal arrhythmia - Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac Arrhythmia: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Cardiac General: Other, capillary leak syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac General: Pericardial effusion (non-malignant)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cardiovascular (Arrhythmia): Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cardiovascular General: Cardiac left ventricular function
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cardiovascular/General: Other (Specify, venous valve)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood cholesterol
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Coagulation: Other (Specify, bruising to lower extremities)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Coagulation: INR (International Normalized Ration of prothrombin time)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 30 at risk

Adverse event: Coagulation: Other (Specify, positive lupus anticoagulant)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Coagulation: thrombotic microangiopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Constitutional Symptoms: Rigors/Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Constitutional Symptoms: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Constitutional Symptoms: Weight gain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Death: Death not associated with CTCAE term: Disease progression NOS
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Dermatology/Skin: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Chelitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Dermatology/Skin: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 30 at risk

Adverse event: Dermatology/Skin: Injection site reaction/extravasation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Pruritis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Pruritis/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Dermatology/Skin: Radiation dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 30 at risk

Adverse event: Dermatology/Skin: Rash: dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Dermatology/Skin: Ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin: Urticaria (hives, welts, wheals)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Dermatology/Skin: Bruising (in absence of Grade 3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Endocrine: Hot flashes/Flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 30 at risk

Adverse event: Flexion contracture, left knee (musculoskeletal, other)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Endocrine: Other (Specify, secondary ovarian failure)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal: Other (Specify, early satiety)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal: Distention/bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal: Mucositis/stomatitis - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal: Ascites (non-malignant)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Gastrointestinal: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Gastrointestinal:
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea associated with graft versus host disease (GVHD) for BMT studies, if specified in the protocol.
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Gastrointestinal: Esophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal: Gastritis (including bile reflux gastritis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal: Mucositis/stomatitis (functional/symptomatic)::Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal: Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal:other, specify::Cholestasis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Gastrointestinal: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal: Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal: Dental:Teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hematochezia/rectal bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Haemolytic uraemic syndrome
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding: Hematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding: Hemorrhage, GU::Urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding: Hemorrhage, pulmonary/upper respiratory::Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hemorrhage::Rectal bleeding/hematochezia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hemorrhage: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hepatic: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hepatic:Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hepatobiliary/Pancreas:: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hepatobiliary/Pancreas:: Pancreatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Increased perirectal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Infection: Other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Infection - Other (Specify, abrasion right great toe)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection - Select - Renal/Genitourinary-kidney
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection General::Wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection/Febrile neutropenia::Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with a grade 3 or 4 neutropenia
Frequency: 1 affected / 30 at risk

Adverse event: Infection::Infection (documented clincally or micro) with grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (ANC \< 1.0x109/l)
Frequency: 3 affected / 30 at risk

Adverse event: Infection::Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Infection::Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically)with Grade 3 or 4 neutrophils (ANC \<1.0x10e9/l)::Oral cavity-gums (gingivitis)
Frequency: 1 affected / 30 at risk

Adverse event: Infection::Infection with normal ANC or Grade 1 or 2 neutrophils::Gluteal abscess left side
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection::Infection with normal ANC or Grade 1 or 2 neutrophils::Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection::Infection with unknown ANC::Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection::Infection with unknown ANC::Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection::Opportunistic infection associated with > grade 2 lymphopenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection::Infection - Other (Specify, clostridium difficile)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Interstitial nephritis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Left hip pain/left groin pain (musculoskeletal)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Lymphatics::Edema:head and neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Lymphatics::Lymphatics - Other (Specify, palpable inguinal adenopathy)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Lymphedema, left LE
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Other, (Specify, BUN, high)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Metabolic/Laboratory: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Hemogloginuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Metabolic/Laboratory: Other, (Specify, LDH)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 30 at risk

Adverse event: Metabolic/Laboratory:Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 30 at risk

Adverse event: Metabolic/Laboratory: Other, urine protein
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 30 at risk

Adverse event: Mild erythema (IV access site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mild fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mucositis of throat and rectal area
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mult. abdominal ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft tissue: Cervical spine-range of motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft tissue: Extremity-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft tissue: Extremity-lower (gait/walking)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft tissue: Muscle weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft tissue: Muscular/Skeletal hypoplasia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neurology: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neurology:Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neurology: Confusion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neurology: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neurology: neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neurology: other
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ocular/Visual:Dry eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other (Specify, pain at site of biopsy)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: Breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - right lateral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Select: Renal/Genitourinary - Kidney
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain with defecation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain/Dermatology/Skin::Face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain/Dermatology/Skin::Oral
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain/Gastrointestinal::Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 30 at risk

Adverse event: Pain/General::Tumor pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain/Musculoskeletal::Extremity-limb, upper
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal::Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Pain/Musculoskeletal::Oral cavity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain/Myalgia (Muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain/Neurology::Neuralgia/peripheral nerve
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain/Pulmonary/Upper Respiratory::Throat/pharynx/Larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Pain/Sexual/Reproductive Function::Urethra
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain:Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain:Earache
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain:General
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain:Musculoskeletal - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pain:Other back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain: Other hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain: Other leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain: Other neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain: Other upper right quadrant
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain: Pelvis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain:Tumor
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 30 at risk

Adverse event: Pain:Dermatology/Skin - Oral gums
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain: Gastrointestinal - Anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain::General - Tumor pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain::Pain - Other (Specify, surgical incision pain)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Pain::Pain - Select: Sexual/Reproductive Function - Scrotum
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain::Pain:: Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain::Pain::Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 30 at risk

Adverse event: Pain::Pain::Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 30 at risk

Adverse event: Pain::Pain::Chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain::Pain::Chest/thorax NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain::Pain::Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Pain::Pain::Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pain::Pain::Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 30 at risk

Adverse event: Pain::Pain::Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain::Pain::Paraspinal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain::Pain::Throat/pharynx/larynx
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain::Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain::Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain::Rectal or perirectal pain (Proctalgia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Perirectal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Proctitis/perirectal skin breakdown
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory::Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory:Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory: Fev1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory:pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory: Pulmonary/Upper Respiratory: Other (Specify, crackles)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pulmonary: Pulmonary Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary:Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Radiodermatitis, right lateral leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Renal/Genitourinary::Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Renal/Genitourinary::Obstruction, GU::Ureter
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Renal/Genitourinary::Stricture/Stenosis, GU - Select, left hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Renal/Genitourinary::Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Renal/Genitourinary::Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sexual/Reproductive Function - Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 30 at risk

Adverse event: Sexual/Reproductive::Other
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sore rib cage on left side
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Ulcerations - soft palate
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: URI/Sinusitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vascular::Vessel injury - vein-Select:Other NOS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Verrucae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Low grade fevers
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary emboli, B/L
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Infection: General, catheter related
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Death
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk