Study: NCT00069238

Adverse event: DEATH:: Death related to the study
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 31 at risk

Adverse event: DEATH:: Death due to progression
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 31 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Upper GI Not otherwise specified (NOS)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 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 \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L):: Blood
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically)
Serious: yes
Organ System: Infections and infestations
Notes: with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L):: Brain (encephalitis, infectious)
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: yes
Organ System: Infections and infestations
Notes: (ANC \<1.0 x 10e9/L):: Lung (pneumonia)
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection with unknown ANC:: Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: RENAL/GENITOURINARY:: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31 at risk

Adverse event: RENAL/GENITOURINARY:: Urinary frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 31 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 9 affected / 31 at risk

Adverse event: AUDITORY/EAR:: Otitis, middle ear (non-infectious)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: AUDITORY/EAR:: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 31 at risk

Adverse event: BLOOD/BONE MARROW:: Bone marrow cellularity
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 31 at risk

Adverse event: BLOOD/BONE MARROW:: Hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 31 at risk

Adverse event: BLOOD/BONE MARROW:: Leukocytes (total white blood count (WBC))
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 31 at risk

Adverse event: BLOOD/BONE MARROW:: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 31 at risk

Adverse event: BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Absolute neutrophil count/absolute granulocyte count (ANC/AGC)
Frequency: 30 affected / 31 at risk

Adverse event: BLOOD/BONE MARROW:: Platelets
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 31 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 31 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus bradycardia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Supraventricular arrhythmia NOS
Serious: no
Organ System: General disorders
Notes: Not otherwise specified (NOS)
Frequency: 1 affected / 31 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Supraventricular tachycardia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Vasovagal episode
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: CARDIAC GENERAL:: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: CARDIAC GENERAL:: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 31 at risk

Adverse event: COAGULATION:: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 31 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 18 affected / 31 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS
Serious: no
Organ System: General disorders
Notes: Fever (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)
Frequency: 11 affected / 31 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 31 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 9 affected / 31 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Weight loss
Serious: no
Organ System: General disorders
Frequency: 7 affected / 31 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: 1 affected / 31 at risk

Adverse event: DERMATOLOGY/SKIN:: Dermatology/Skin - Other (Specify, excoriation)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: DERMATOLOGY/SKIN:: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: DERMATOLOGY/SKIN:: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: DERMATOLOGY/SKIN:: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 31 at risk

Adverse event: DERMATOLOGY/SKIN:: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: DERMATOLOGY/SKIN:: Nail changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 31 at risk

Adverse event: DERMATOLOGY/SKIN:: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 31 at risk

Adverse event: DERMATOLOGY/SKIN:: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 31 at risk

Adverse event: DERMATOLOGY/SKIN:: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Dental: teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Esophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Gastritis (including bile reflux gastritis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal - Other (Specify, duodenitis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Mucositis/stomatitis (clinical exam):: Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Mucositis/stomatitis (clinical exam):: Pharynx
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Esophagus
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Typhlitis (cecal inflammation)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 31 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Lower GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not otherwise specified (NOS)
Frequency: 1 affected / 31 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Upper GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Bladder
Serious: no
Organ System: Renal and urinary disorders
Notes: Genitourinary (GU)
Frequency: 1 affected / 31 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Bronchopulmonary NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Nose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage/Bleeding - Other (Specify, R. neck after picc line)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 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 / 31 at risk

Adverse event: INFECTION:: Febrile neutropenia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: (fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 16 affected / 31 at risk

Adverse event: INFECTION:: Infection(documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (ANC \<1.0 x 10e9/L):: Abdomen NOS
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (ANC \<1.0 x 10e9/L):: Bladder (urinary)
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (ANC \<1.0 x 10e9/L):: Blood
Frequency: 4 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (ANC \<1.0 x 10e9/L):: Brain (encephalitis, infectious)
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Nervous system disorders
Notes: (ANC \<1.0 x 10e9/L):: Catheter-related
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Nervous system disorders
Notes: (ANC \<1.0 x 10e9/L):: Cecum
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Nervous system disorders
Notes: (ANC \<1.0 x 10e9/L):: Colon
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Nervous system disorders
Notes: (ANC \<1.0 x 10e9/L):: Conjunctiva
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Nervous system disorders
Notes: (ANC \<1.0 x 10e9/L):: Lung (pneumonia)
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (ANC \<1.0 x 10e9/L):: Mucosa
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (ANC \<1.0 x 10e9/L):: Spleen
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (Absolute neutrophil count (ANC) \<1.0 x 10e9/L):: Urinary tract NOS
Frequency: 4 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (ANC \<1.0 x 10e9/L):: Vein
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: (ANC \<1.0 x 10e9/L):: Wound
Frequency: 2 affected / 31 at risk

Adverse event: INFECTION:: Infection - Other (Specify, BLOOD)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Blood
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Sinus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 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 / 31 at risk

Adverse event: INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Notes: Not otherwise specified (NOS)
Frequency: 4 affected / 31 at risk

Adverse event: INFECTION:: Infection with unknown ANC:: Blood
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection with unknown ANC:: Oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION:: Infection with unknown ANC:: Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: LYMPHATICS:: Edema: head and neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: LYMPHATICS:: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 31 at risk

Adverse event: LYMPHATICS:: Edema: trunk/genital
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: alanine aminotransferase (ALT), serum glutamic pyruvic transaminase (SGPT)
Frequency: 14 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: aspartate aminotransferase (AST), serum glutamic oxaloacetic transaminase (SGOT)
Frequency: 14 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 31 at risk

Adverse event: METABOLIC/LABORATORY:: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 31 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE:: Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE:: Joint-effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 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: 1 affected / 31 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: Whole body/generalized
Frequency: 1 affected / 31 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE:: Musculoskeletal/Soft Tissue - Other (Specify, __)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: cervical spine range of motion
Frequency: 1 affected / 31 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE:: Soft tissue necrosis:: Extremity-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: NEUROLOGY:: Confusion
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 31 at risk

Adverse event: NEUROLOGY:: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 31 at risk

Adverse event: NEUROLOGY:: Laryngeal nerve dysfunction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: NEUROLOGY:: Mood alteration:: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: NEUROLOGY:: Mood alteration:: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 31 at risk

Adverse event: NEUROLOGY:: Mood alteration:: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: NEUROLOGY:: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 31 at risk

Adverse event: NEUROLOGY:: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 31 at risk

Adverse event: NEUROLOGY:: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: NEUROLOGY:: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: NEUROLOGY:: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: OCULAR/VISUAL:: Ocular/Visual - Other (Specify, red eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: OCULAR/VISUAL:: Ophthalmoplegia/diplopia (double vision)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: OCULAR/VISUAL:: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 31 at risk

Adverse event: OCULAR/VISUAL:: Vision-photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: OCULAR/VISUAL:: Watery eye (epiphora, tearing)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain - Other (Specify, L wrist)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain:: Abdomen Not otherwise specified (NOS)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 31 at risk

Adverse event: PAIN:: Pain:: Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 31 at risk

Adverse event: PAIN:: Pain:: Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain:: Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 31 at risk

Adverse event: PAIN:: Pain:: Buttock
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain:: Chest/thorax NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 31 at risk

Adverse event: PAIN:: Pain:: Dental/teeth/peridontal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain:: Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain:: Eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: PAIN:: Pain:: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 31 at risk

Adverse event: PAIN:: Pain:: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 31 at risk

Adverse event: PAIN:: Pain:: Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 31 at risk

Adverse event: PAIN:: Pain:: Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain:: Rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain:: Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 31 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 31 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: RENAL/GENITOURINARY:: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 31 at risk

Adverse event: RENAL/GENITOURINARY:: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31 at risk

Adverse event: RENAL/GENITOURINARY:: Obstruction, GU:: Ureter
Serious: no
Organ System: Renal and urinary disorders
Notes: Genitourinary (GU)
Frequency: 1 affected / 31 at risk

Adverse event: RENAL/GENITOURINARY:: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 31 at risk

Adverse event: VASCULAR:: Phlebitis (including superficial thrombosis)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: VASCULAR:: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 31 at risk

Adverse event: VASCULAR:: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 31 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal - Other (Specify, tongue-blue spot)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: OCULAR/VISUAL:: Ocular/Visual - Other (Specify, dilated, non-reactive R.pupil
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain - Other (Specify, lumbar puncture (LP) site)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain - Other (Specify, Pain L big toe
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain - Other (Specify, Pain: jaw pain)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain - Other (Specify, Pain:teeth)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain - Other (Specify, Pain: tooth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN:: Pain - Other (Specify, Pain:groin)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 31 at risk