Study: NCT00081939

Adverse event: Grade 3 Allergic reaction/hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 7 affected / 303 at risk

Adverse event: Grade 4 Allergic reaction/Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 4 Allergy-other
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Autoimmune reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 303 at risk

Adverse event: Grade 3 Anemia (HGB)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 139 affected / 303 at risk

Adverse event: Grade 4 Anemia (HGB)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 48 affected / 303 at risk

Adverse event: Grade 3 CD4 count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Neutropenia/granulocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 303 at risk

Adverse event: Grade 4 Neutropenia/granulocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 115 affected / 303 at risk

Adverse event: Grade 3 Thrombocytopenia (PLT)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 303 at risk

Adverse event: Grade 4 Thrombocytopenia (PLT)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 296 affected / 303 at risk

Adverse event: Grade 4 Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 303 affected / 303 at risk

Adverse event: Grade 3 AV Block-Type 2
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 5 Asystole
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Febrile Neutropenia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 303 at risk

Adverse event: Grade 4 Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Left vent. systolic dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 4 Left vent systolic dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Supra Arrhythmia: atrial fib.
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 303 at risk

Adverse event: Grade 4 Supra Arrhyth: Atrial Fib
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Supra Arrhyth: Atrial Flut
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Supra Arrhyth: Sinus Brady
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 4 Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Vasovagal episode
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 5 Vent arrhyth: Bigeminy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Ventricular Arrythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 303 at risk

Adverse event: Grade 4 Ventricular Arrythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 5 Ventricular Arrythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Cardiac General
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 4 Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 4 Cardiopulmonary arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 303 at risk

Adverse event: Grade 3 Coagulation-other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Constitutional symptoms-other
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 303 at risk

Adverse event: Grade 4 Constitutional symptoms-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 5 Constitutional symptoms-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Fatigue-lethargy, malaise, asthenia
Serious: yes
Organ System: General disorders
Frequency: 157 affected / 303 at risk

Adverse event: Grade 4 Fatigue-lethargy, malaise, asthenia
Serious: yes
Organ System: General disorders
Frequency: 36 affected / 303 at risk

Adverse event: Grade 3 Fatigue-malaise, lethargy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Fever (in absence of neutropenia)
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 303 at risk

Adverse event: Grade 5 Fever (absence of neutropenia)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Insomnia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 4 Insomnia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Obesity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Sweating
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Weight loss
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Weight gain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Dermatology-other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Skin rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 303 at risk

Adverse event: Grade 4 Skin rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Ulceration
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Diabetes
Serious: yes
Organ System: Endocrine disorders
Frequency: 12 affected / 303 at risk

Adverse event: Grade 3 Hot flashes
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Anorexia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 107 affected / 303 at risk

Adverse event: Grade 4 Anorexia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 303 at risk

Adverse event: Grade 3 Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 303 at risk

Adverse event: Grade 4 Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 5 Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 303 at risk

Adverse event: Grade 4 Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 303 at risk

Adverse event: Grade 3 Diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 303 at risk

Adverse event: Grade 4 Diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Dry mouth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 303 at risk

Adverse event: Grade 3 Esophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 303 at risk

Adverse event: Grade 3 GI Necrosis gallblader
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 GI Obstruction cecum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 4 GI Obstruction cecum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 GI Perforation appendix
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 303 at risk

Adverse event: Grade 3 Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Heartburn
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Hemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Mucositis/Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 303 at risk

Adverse event: Grade 4 Mucositis/Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 303 at risk

Adverse event: Grade 4 Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Taste alteration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 303 at risk

Adverse event: Grade 4 Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Hematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Hemorrhage, lower GI
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 4 Hemorrhage, lower GI
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Hemorrhage, upper GI
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Hemorrhage-other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Alkaline phosphatase increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 303 at risk

Adverse event: Grade 3 Bilirubin increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 303 at risk

Adverse event: Grade 4 Bilirubin increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 303 at risk

Adverse event: Grade 4 Bilirubin increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Hypoalbuminemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 53 affected / 303 at risk

Adverse event: Grade 3 SGOT (AST) increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 303 at risk

Adverse event: Grade 4 SGOT (AST) increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 SGPT (ALT) increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 18 affected / 303 at risk

Adverse event: Grade 4 SGPT (ALT) increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Colitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 303 at risk

Adverse event: Grade 4 Colitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Febrile neutropenia (ANC, fever)
Serious: yes
Organ System: Infections and infestations
Frequency: 103 affected / 303 at risk

Adverse event: Grade 4 Febrile neutropenia (ANC, fever)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 GI Infection 3-4 ANC abdomen
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 303 at risk

Adverse event: Grade 3 GI Infection 3-4 ANC Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 GI Infection 3-4 ANC Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 GI Infection Unk ANC Abdomen
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 GU Infection 3-4 ANC Bladder
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 GU Infection Unk ANC UTI
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Infection 3-4 ANC Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 303 at risk

Adverse event: Grade 4 Infection 3-4 ANC Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Infection 3-4 ANC Cath-related
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Infection 3-4 ANC Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Infection Unk ANC Cath-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Infection Unk ANC for body
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Infection (documented clinically or microbiologically)
Serious: yes
Organ System: Infections and infestations
Frequency: 29 affected / 303 at risk

Adverse event: Grade 3 Infection w/normal ANC Musculoskeletal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Infection w/normal ANC skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Infection w/normal ANC GI mild
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Infection w/normal ANC Dermatology
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Infection w/normal ANC Gastrointestinal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Infection w/normal ANC General
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 303 at risk

Adverse event: Grade 3 Infection w/normal ANC Neurology
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Infection w/normal ANC Renal/Genitourinary
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Infection w/unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 5 Infection w/unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Infection Clinical Doc. w/high ANC/Pulmonary
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Infection Normal ANC Lung (Bronchus)
Serious: yes
Organ System: Infections and infestations
Frequency: 28 affected / 303 at risk

Adverse event: Grade 3 Infection Normal Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 303 at risk

Adverse event: Grade 3 Infection other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Lung infection-Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 303 at risk

Adverse event: Grade 3 Lung Infection-lung
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 303 at risk

Adverse event: Grade 5 Lung infection-lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Lung infection-sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 303 at risk

Adverse event: Grade 3 Lung infection-upper airway
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Lung infection Unk ANC-bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 303 at risk

Adverse event: Grade 3 Lung infection Unk ANC-lung
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 303 at risk

Adverse event: Grade 3 Lung infection normal ANC-nose
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Opportunistic infection associated w/lymphopenia
Serious: yes
Organ System: Infections and infestations
Frequency: 110 affected / 303 at risk

Adverse event: Grade 4 Opportunistic infection associated w/lymphopenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 5 Opportunistic infection associated w/lymphopenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Viral hepatitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 5 Lung infection Unk ANC-bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Skin infection Unk ANC-skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Edema-head and neck
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Edema-limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 303 at risk

Adverse event: Grade 3 Edema-trunk/genital
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Lymphatics-other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Bicarbonate decrease
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 303 at risk

Adverse event: Grade 4 Bicarbonate decrease
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 303 at risk

Adverse event: Grade 3 GGT(Gamma-glutamyl transferase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Hypercalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 4 Hypercalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 303 at risk

Adverse event: Grade 3 Hyperglycemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 109 affected / 303 at risk

Adverse event: Grade 4 Hyperglycemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 303 at risk

Adverse event: Grade 3 Hyperkalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 303 at risk

Adverse event: Grade 4 Hyperkalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 303 at risk

Adverse event: Grade 3 Hypermagnesemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 303 at risk

Adverse event: Grade 4 Hypermagnesemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Hypernatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Hypocalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 98 affected / 303 at risk

Adverse event: Grade 4 Hypocalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 303 at risk

Adverse event: Grade 3 Hypokalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 120 affected / 303 at risk

Adverse event: Grade 4 Hypokalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 303 at risk

Adverse event: Grade 3 Hypomagnesemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 303 at risk

Adverse event: Grade 4 Hypomagnesemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Hyponatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 186 affected / 303 at risk

Adverse event: Grade 4 Hyponatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 303 at risk

Adverse event: Grade 3 Hypophosphatemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 236 affected / 303 at risk

Adverse event: Grade 4 Hypophosphatemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 303 at risk

Adverse event: Grade 3 Device/prosthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 303 at risk

Adverse event: Grade 3 Gait/walking
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 303 at risk

Adverse event: Grade 4 Gait/walking
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Muscle weakness-lower extrem.
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 4 Muscle weakness-whole body
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Muscle weakness-whole body
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 303 at risk

Adverse event: Grade 3 Musculoskeletal-other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 303 at risk

Adverse event: Grade 3 Soft tissue-abdomen
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 303 at risk

Adverse event: Grade 3 CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 4 CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Confusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 303 at risk

Adverse event: Grade 4 Confusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 303 at risk

Adverse event: Grade 3 Dizziness (includes lightneadedness, disequilibrium & vertigo)
Serious: yes
Organ System: Nervous system disorders
Frequency: 29 affected / 303 at risk

Adverse event: Grade 4 Dizziness (includes lightheadedness, disequilibrium & vertigo)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 303 at risk

Adverse event: Grade 3 Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Involuntary movement
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Irritability
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 4 Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Mental status
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Mood alteration (agitation, anxiety, depression, euphoria)
Serious: yes
Organ System: Nervous system disorders
Frequency: 22 affected / 303 at risk

Adverse event: Grade 4 Mood alteration (agitation, anxiety, depression, euphoria)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Mood/conscious change
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Neurology-other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 71 affected / 303 at risk

Adverse event: Grade 4 Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 303 at risk

Adverse event: Grade 3 Psychosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Sensory Neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 73 affected / 303 at risk

Adverse event: Grade 4 Sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 303 at risk

Adverse event: Grade 3 Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 303 at risk

Adverse event: Grade 4 Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 30 affected / 303 at risk

Adverse event: Grade 4 Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 303 at risk

Adverse event: Grade 3 Weakness-motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Blurred vision
Serious: yes
Organ System: Eye disorders
Frequency: 8 affected / 303 at risk

Adverse event: Grade 3 Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 6 affected / 303 at risk

Adverse event: Grade 3 Flashing lights
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Ocular-other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Photophobia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 303 at risk

Adverse event: Grade 3 Anus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Bone
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 303 at risk

Adverse event: Grade 3 Buttock
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Cardiac/heart
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 3 Chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 303 at risk

Adverse event: Grade 3 Chest wall
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Esophagus
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 External ear
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Extremity/limb
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 303 at risk

Adverse event: Grade 4 Extremity/limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Face
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Head/headache
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 303 at risk

Adverse event: Grade 3 Hip-left
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 303 at risk

Adverse event: Grade 3 Hip-right
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 303 at risk

Adverse event: Grade 3 Joint
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 303 at risk

Adverse event: Grade 4 Joint
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Kidney
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Lower back
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 303 at risk

Adverse event: Grade 4 Lower back
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 303 at risk

Adverse event: Grade 3 Middle back
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 303 at risk

Adverse event: Grade 3 Muscle
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 303 at risk

Adverse event: Grade 3 Neck
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 303 at risk

Adverse event: Grade 3 Neuralgia/peripheral nerve
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Oral cavity
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Pain NOS
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 303 at risk

Adverse event: Grade 3 Pleura
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Rectum
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Rib
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Sinus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Skin
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Stomach
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 303 at risk

Adverse event: Grade 3 Throat pharynx/larynx
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 303 at risk

Adverse event: Grade 4 Throat pharynx/larynx
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Tumor pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 4 Tumor pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Upper back
Serious: yes
Organ System: General disorders
Frequency: 26 affected / 303 at risk

Adverse event: Grade 4 Upper back
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 303 at risk

Adverse event: Grade 4 ARDS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 303 at risk

Adverse event: Grade 5 Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 303 at risk

Adverse event: Grade 3 DLCO
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 303 at risk

Adverse event: Grade 4 Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Hiccoughs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 58 affected / 303 at risk

Adverse event: Grade 4 Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 5 Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 303 at risk

Adverse event: Grade 4 Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 4 Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Prolonged intubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Pulmonary-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 303 at risk

Adverse event: Grade 3 Bladder spasms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 303 at risk

Adverse event: Grade 4 Bladder spasms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Creatinine increase
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 23 affected / 303 at risk

Adverse event: Grade 4 Creatinine increase
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 303 at risk

Adverse event: Grade 3 GU fistula-bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Incontinence-urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 303 at risk

Adverse event: Grade 3 Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 303 at risk

Adverse event: Grade 4 Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 303 at risk

Adverse event: Grade 3 Renal-other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 303 at risk

Adverse event: Grade 3 Urinary frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 13 affected / 303 at risk

Adverse event: Grade 3 Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Secondary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 303 at risk

Adverse event: Grade 4 Secondary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Sexual-other
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 HN Operative Injury-neck
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Muscle operative Injury-joint
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 303 at risk

Adverse event: Grade 3 Operative Injury-other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 303 at risk

Adverse event: Grade 3 Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 48 affected / 303 at risk

Adverse event: Grade 4 Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 303 at risk

Adverse event: Grade 3 Thrombosis/embolism (vasc acc)
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 303 at risk

Adverse event: Grade 4 Thrombosis/embolism (vasc acc)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 303 at risk

Adverse event: Grade 1 Allergic reaction/hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 69 affected / 303 at risk

Adverse event: Grade 2 Allergic reaction/hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 27 affected / 303 at risk

Adverse event: Grade 1 Rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 43 affected / 303 at risk

Adverse event: Grade 2 Rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 19 affected / 303 at risk

Adverse event: Grade 1 Auditory/ear-other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 16 affected / 303 at risk

Adverse event: Grade 2 Hearing w/o monitoring program
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 16 affected / 303 at risk

Adverse event: Grade 2 Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 31 affected / 303 at risk

Adverse event: Grade 2 Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 112 affected / 303 at risk

Adverse event: Grade 1 Ventricular Arrythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 52 affected / 303 at risk

Adverse event: Grade 2 Ventricular Arrythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 58 affected / 303 at risk

Adverse event: Grade 1 Constitutional symptoms-other
Serious: no
Organ System: General disorders
Frequency: 48 affected / 303 at risk

Adverse event: Grade 2 Constitutional symptoms-other
Serious: no
Organ System: General disorders
Frequency: 17 affected / 303 at risk

Adverse event: Grade 2 Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 84 affected / 303 at risk

Adverse event: Grade 1 Fever (absence of neutropenia)
Serious: no
Organ System: General disorders
Frequency: 131 affected / 303 at risk

Adverse event: Grade 2 Fever (absence of neutropenia)
Serious: no
Organ System: General disorders
Frequency: 82 affected / 303 at risk

Adverse event: Grade 1 Insomnia
Serious: no
Organ System: General disorders
Frequency: 53 affected / 303 at risk

Adverse event: Grade 2 Insomnia
Serious: no
Organ System: General disorders
Frequency: 26 affected / 303 at risk

Adverse event: Grade 1 Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 47 affected / 303 at risk

Adverse event: Grade 1 Sweating
Serious: no
Organ System: General disorders
Frequency: 54 affected / 303 at risk

Adverse event: Grade 2 Sweating
Serious: no
Organ System: General disorders
Frequency: 22 affected / 303 at risk

Adverse event: Grade 1 Weight loss
Serious: no
Organ System: General disorders
Frequency: 17 affected / 303 at risk

Adverse event: Grade 1 Weight gain
Serious: no
Organ System: General disorders
Frequency: 44 affected / 303 at risk

Adverse event: Grade 1 Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 303 at risk

Adverse event: Grade 2 Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 61 affected / 303 at risk

Adverse event: Grade 1 Dermatology-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 303 at risk

Adverse event: Grade 2 Dermatology-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 303 at risk

Adverse event: Grade 1 Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 50 affected / 303 at risk

Adverse event: Grade 2 Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 303 at risk

Adverse event: Grade 1 Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 303 at risk

Adverse event: Grade 1 Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 303 at risk

Adverse event: Grade 1 Skin rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 100 affected / 303 at risk

Adverse event: Grade 2 Skin rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 82 affected / 303 at risk

Adverse event: Grade 1 Hot flashes
Serious: no
Organ System: Endocrine disorders
Frequency: 15 affected / 303 at risk

Adverse event: Grade 2 Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 22 affected / 303 at risk

Adverse event: Grade 1 Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 303 at risk

Adverse event: Grade 2 Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 133 affected / 303 at risk

Adverse event: Grade 1 Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 303 at risk

Adverse event: Grade 2 Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 303 at risk

Adverse event: Grade 1 Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 122 affected / 303 at risk

Adverse event: Grade 2 Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 107 affected / 303 at risk

Adverse event: Grade 1 Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 303 at risk

Adverse event: Grade 2 Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 303 at risk

Adverse event: Grade 1 Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 303 at risk

Adverse event: Grade 2 Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 111 affected / 303 at risk

Adverse event: Grade 1 Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 303 at risk

Adverse event: Grade 2 Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 303 at risk

Adverse event: Grade 1 Dysphagisa
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 303 at risk

Adverse event: Grade 2 Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 303 at risk

Adverse event: Grade 1 Esophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 303 at risk

Adverse event: Grade 2 Esophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 65 affected / 303 at risk

Adverse event: Grade 1 GI-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 303 at risk

Adverse event: Grade 1 Heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 303 at risk

Adverse event: Grade 1 Mucositis/Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 96 affected / 303 at risk

Adverse event: Grade 2 Mucositis/Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 303 at risk

Adverse event: Grade 1 Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 303 at risk

Adverse event: Grade 2 Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 149 affected / 303 at risk

Adverse event: Grade 1 Taste alteration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 303 at risk

Adverse event: Grade 2 Taste alteration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 303 at risk

Adverse event: Grade 1 Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 303 at risk

Adverse event: Grade 2 Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 108 affected / 303 at risk

Adverse event: Grade 1 Hemorrhage-lower GI
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 303 at risk

Adverse event: Grade 1 Alkaline phosphatase increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 181 affected / 303 at risk

Adverse event: Grade 2 Alkaline phosphatase increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 31 affected / 303 at risk

Adverse event: Grade 1 Bilirubin increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 78 affected / 303 at risk

Adverse event: Grade 2 Bilirubin increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 26 affected / 303 at risk

Adverse event: Grade 1 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 40 affected / 303 at risk

Adverse event: Grade 2 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 208 affected / 303 at risk

Adverse event: Grade 1 SGOT (AST) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 171 affected / 303 at risk

Adverse event: Grade 2 SGOT (AST) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 28 affected / 303 at risk

Adverse event: Grade 1 SGPT (ALT) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 168 affected / 303 at risk

Adverse event: Grade 2 SGPT (ALT) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 45 affected / 303 at risk

Adverse event: Grade 2 Opportunistic infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 303 at risk

Adverse event: Grade 2 Infection (documented clinically or microbiologically)
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 303 at risk

Adverse event: Grade 1 Edema-head and neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 303 at risk

Adverse event: Grade 1 Edema-limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 118 affected / 303 at risk

Adverse event: Grade 2 Edema-limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 36 affected / 303 at risk

Adverse event: Grade 1 Lymphatics-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 303 at risk

Adverse event: Grade 1 Bicarbonate decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 219 affected / 303 at risk

Adverse event: Grade 2 Bicarbonate decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 303 at risk

Adverse event: Grade 1 Hypercalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 303 at risk

Adverse event: Grade 1 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 303 at risk

Adverse event: Grade 2 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 165 affected / 303 at risk

Adverse event: Grade 1 Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 95 affected / 303 at risk

Adverse event: Grade 2 Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 303 at risk

Adverse event: Grade 1 Hypermagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 303 at risk

Adverse event: Grade 1 Hypernatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 303 at risk

Adverse event: Grade 2 Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 151 affected / 303 at risk

Adverse event: Grade 1 Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 162 affected / 303 at risk

Adverse event: Grade 1 Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 75 affected / 303 at risk

Adverse event: Grade 2 Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 303 at risk

Adverse event: Grade 1 Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 104 affected / 303 at risk

Adverse event: Grade 2 Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 54 affected / 303 at risk

Adverse event: Grade 1 Gait/walking
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 303 at risk

Adverse event: Grade 1 Joint-function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 303 at risk

Adverse event: Grade 1 Muscle weakness-whole body
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 303 at risk

Adverse event: Grade 2 Muscle weakness-whole body
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 303 at risk

Adverse event: Grade 1 Musculoskeletal-other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 46 affected / 303 at risk

Adverse event: Grade 1 Confusion
Serious: no
Organ System: Nervous system disorders
Frequency: 66 affected / 303 at risk

Adverse event: Grade 2 Confusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 303 at risk

Adverse event: Grade 1 Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 96 affected / 303 at risk

Adverse event: Grade 2 Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 72 affected / 303 at risk

Adverse event: Grade 1 Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 303 at risk

Adverse event: Grade 2 Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 303 at risk

Adverse event: Grade 1 Mood alteration
Serious: no
Organ System: Nervous system disorders
Frequency: 99 affected / 303 at risk

Adverse event: Grade 2 Mood alteration
Serious: no
Organ System: Nervous system disorders
Frequency: 97 affected / 303 at risk

Adverse event: Grade 1 Neurology-other
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 303 at risk

Adverse event: Grade 1 Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 74 affected / 303 at risk

Adverse event: Grade 2 Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 84 affected / 303 at risk

Adverse event: Grade 1 Sensory -neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 77 affected / 303 at risk

Adverse event: Grade 2 Sensory-neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 118 affected / 303 at risk

Adverse event: Grade 2 Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 303 at risk

Adverse event: Grade 1 Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 303 at risk

Adverse event: Grade 2 Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 303 at risk

Adverse event: Grade 1 Blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 146 affected / 303 at risk

Adverse event: Grade 2 Blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 32 affected / 303 at risk

Adverse event: Grade 1 Ocular-other
Serious: no
Organ System: Eye disorders
Frequency: 24 affected / 303 at risk

Adverse event: Grade 1 Abdomen
Serious: no
Organ System: General disorders
Frequency: 31 affected / 303 at risk

Adverse event: Grade 2 Bone
Serious: no
Organ System: General disorders
Frequency: 16 affected / 303 at risk

Adverse event: Grade 1 Chest-thorax
Serious: no
Organ System: General disorders
Frequency: 16 affected / 303 at risk

Adverse event: Grade 1 Chest wall
Serious: no
Organ System: General disorders
Frequency: 16 affected / 303 at risk

Adverse event: Grade 1 Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 36 affected / 303 at risk

Adverse event: Grade 2 Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 42 affected / 303 at risk

Adverse event: Grade 1 Head-headache
Serious: no
Organ System: General disorders
Frequency: 51 affected / 303 at risk

Adverse event: Grade 2 Head-headache
Serious: no
Organ System: General disorders
Frequency: 25 affected / 303 at risk

Adverse event: Grade 2 Hip-left
Serious: no
Organ System: General disorders
Frequency: 16 affected / 303 at risk

Adverse event: Grade 1 Joint
Serious: no
Organ System: General disorders
Frequency: 29 affected / 303 at risk

Adverse event: Grade 2 Joint
Serious: no
Organ System: General disorders
Frequency: 23 affected / 303 at risk

Adverse event: Grade 1 Lower back
Serious: no
Organ System: General disorders
Frequency: 35 affected / 303 at risk

Adverse event: Grade 2 Lower back
Serious: no
Organ System: General disorders
Frequency: 57 affected / 303 at risk

Adverse event: Grade 1 Middle back
Serious: no
Organ System: General disorders
Frequency: 32 affected / 303 at risk

Adverse event: Grade 2 Middle back
Serious: no
Organ System: General disorders
Frequency: 24 affected / 303 at risk

Adverse event: Grade 1 Muscle
Serious: no
Organ System: General disorders
Frequency: 18 affected / 303 at risk

Adverse event: Grade 1 Neck
Serious: no
Organ System: General disorders
Frequency: 17 affected / 303 at risk

Adverse event: Grade 1 Pain NOS
Serious: no
Organ System: General disorders
Frequency: 48 affected / 303 at risk

Adverse event: Grade 2 Pain NOS
Serious: no
Organ System: General disorders
Frequency: 27 affected / 303 at risk

Adverse event: Grade 1 Stomach
Serious: no
Organ System: General disorders
Frequency: 23 affected / 303 at risk

Adverse event: Grade 1 Throat pharynx-larynx
Serious: no
Organ System: General disorders
Frequency: 15 affected / 303 at risk

Adverse event: Grade 1 Upper back
Serious: no
Organ System: General disorders
Frequency: 57 affected / 303 at risk

Adverse event: Grade 2 Upper back
Serious: no
Organ System: General disorders
Frequency: 76 affected / 303 at risk

Adverse event: Grade 1 Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 158 affected / 303 at risk

Adverse event: Grade 2 Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 72 affected / 303 at risk

Adverse event: Grade 1 Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 303 at risk

Adverse event: Grade 2 Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 303 at risk

Adverse event: Grade 1 Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 303 at risk

Adverse event: Grade 2 Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 66 affected / 303 at risk

Adverse event: Grade 1 Nasal/paranasal reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 303 at risk

Adverse event: Grade 2 Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 303 at risk

Adverse event: Grade 1 Pulmonary-other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 303 at risk

Adverse event: Grade 2 Pulmonary-other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 303 at risk

Adverse event: Grade 1 Creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 112 affected / 303 at risk

Adverse event: Grade 2 Creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 62 affected / 303 at risk

Adverse event: Grade 1 Incontinence-urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 303 at risk

Adverse event: Grade 2 Incontinence-urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 17 affected / 303 at risk

Adverse event: Grade 1 Renal-other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 303 at risk

Adverse event: Grade 1 Urinary frequency-urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 75 affected / 303 at risk

Adverse event: Grade 2 Urinary frequency-urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 303 at risk

Adverse event: Grade 2 Thrombosis/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 29 affected / 303 at risk