Study: NCT00127205

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2125 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2125 at risk

Adverse event: Syndromes-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2125 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2125 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 2125 at risk

Adverse event: Death - Disease progression NOS
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2125 at risk

Adverse event: Secondary Malignancy-poss rel to cancer Tx
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2125 at risk

Adverse event: Sexual/Reproductive Function-Other
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2125 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 376 affected / 2125 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 230 affected / 2125 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 288 affected / 2125 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 138 affected / 2125 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 454 affected / 2125 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 133 affected / 2125 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 158 affected / 2125 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 243 affected / 2125 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 851 affected / 2125 at risk

Adverse event: Fever in absence of neutropenia, ANC lt1.0x10e9/L
Serious: no
Organ System: General disorders
Frequency: 261 affected / 2125 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 108 affected / 2125 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 185 affected / 2125 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 109 affected / 2125 at risk

Adverse event: Rash: dermatitis associated w/radiation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 108 affected / 2125 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 290 affected / 2125 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 308 affected / 2125 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 114 affected / 2125 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 205 affected / 2125 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 366 affected / 2125 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 209 affected / 2125 at risk

Adverse event: Metabolic/Laboratory-Other
Serious: no
Organ System: Investigations
Frequency: 120 affected / 2125 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 160 affected / 2125 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 118 affected / 2125 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 124 affected / 2125 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 109 affected / 2125 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 196 affected / 2125 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 484 affected / 2125 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 119 affected / 2125 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 120 affected / 2125 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 148 affected / 2125 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 172 affected / 2125 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 114 affected / 2125 at risk

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 206 affected / 2125 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 295 affected / 2125 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 614 affected / 2125 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 260 affected / 2125 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1071 affected / 2125 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 488 affected / 2125 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 196 affected / 2125 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 464 affected / 2125 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 310 affected / 2125 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 345 affected / 2125 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 178 affected / 2125 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 236 affected / 2125 at risk

Adverse event: Pain - Breast
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 129 affected / 2125 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 128 affected / 2125 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 216 affected / 2125 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 185 affected / 2125 at risk

Adverse event: Hair loss/Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 138 affected / 2125 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 306 affected / 2125 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 97 affected / 2125 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 795 affected / 2125 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 94 affected / 2125 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 2186 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 2186 at risk

Adverse event: Cardiac General-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Conduction abnorm/AV block - Sick sinus syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2186 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Pain - Cardiac/heart
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2186 at risk

Adverse event: SVT and nodal arrhythmia - Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 2186 at risk

Adverse event: SVT and nodal arrhythmia - Atrial tachycardia/PAT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2186 at risk

Adverse event: SVT and nodal arrhythmia - SVT tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2186 at risk

Adverse event: SVT and nodal arrhythmia - Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2186 at risk

Adverse event: SVT and nodal arrhythmia - Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Endocrine-Other
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Vision-blurred vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Dental: periodontal disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 2186 at risk

Adverse event: Distention/bloating, abdominal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Fistula, GI - Colon/cecum/appendix
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Hemorrhage, GI - Cecum/appendix
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Hemorrhage, GI - Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Hemorrhage, GI - Varices (rectal)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Obstruction, GI - Cecum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Obstruction, GI - Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 2186 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 2186 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 2186 at risk

Adverse event: Perforation, GI - Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Ulcer, GI - Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Death not associated with CTCAE term - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Edema: head and neck
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 2186 at risk

Adverse event: Pain - Pain NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Pain-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Syndromes-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 2186 at risk

Adverse event: Pain - Liver
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Allergic reaction/hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 2186 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 2186 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2186 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2186 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2186 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2186 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Catheter
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2186 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2186 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 2186 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Lymphatic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2186 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Skin
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 2186 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2186 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2186 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutroph
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2186 at risk

Adverse event: Infection with unknown ANC - Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2186 at risk

Adverse event: Infection with unknown ANC - Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2186 at risk

Adverse event: Infection with unknown ANC - Foreign body (e.g., g
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2186 at risk

Adverse event: Infection with unknown ANC - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2186 at risk

Adverse event: Infection with unknown ANC - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 2186 at risk

Adverse event: Infection with unknown ANC - Soft tissue NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2186 at risk

Adverse event: Infection with unknown ANC - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 2186 at risk

Adverse event: Infection-Other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2186 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 2186 at risk

Adverse event: Intra-operative Injury-Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2186 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2186 at risk

Adverse event: Vessel injury-artery - Carotid
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2186 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 2186 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 2186 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2186 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2186 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2186 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 2186 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2186 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 2186 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 2186 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 2186 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 2186 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 2186 at risk

Adverse event: Musculoskeletal/Soft Tissue-Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 2186 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Pain - Bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Pain - Chest wall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Pain - Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Pain - Joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Pain - Muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 2186 at risk

Adverse event: Death - Disease progression NOS
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2186 at risk

Adverse event: Pain - Tumor pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2186 at risk

Adverse event: Secondary Malignancy-poss rel to cancer Tx
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2186 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2186 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 2186 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 2186 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Neurology-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 2186 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 2186 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 2186 at risk

Adverse event: Personality/behavioral
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Glomerular filtration rate
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Obstruction, GU - Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Renal/Genitourinary-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Hemorrhage, GU - Uterus
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Bronchospasm, wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 2186 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2186 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2186 at risk

Adverse event: Pulmonary/Upper Respiratory-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Dermatology/Skin-Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Rash: erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2186 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2186 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 2186 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 326 affected / 2186 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 259 affected / 2186 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 447 affected / 2186 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 332 affected / 2186 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 555 affected / 2186 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 146 affected / 2186 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 243 affected / 2186 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 212 affected / 2186 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 749 affected / 2186 at risk

Adverse event: Fever in absence of neutropenia, ANC lt1.0x10e9/L
Serious: no
Organ System: General disorders
Frequency: 82 affected / 2186 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 24 affected / 2186 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 149 affected / 2186 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 27 affected / 2186 at risk

Adverse event: Rash: dermatitis associated w/radiation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 100 affected / 2186 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 540 affected / 2186 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 581 affected / 2186 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 166 affected / 2186 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 230 affected / 2186 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 370 affected / 2186 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 181 affected / 2186 at risk

Adverse event: Metabolic/Laboratory-Other
Serious: no
Organ System: Investigations
Frequency: 132 affected / 2186 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 213 affected / 2186 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 140 affected / 2186 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 137 affected / 2186 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 97 affected / 2186 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 162 affected / 2186 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 429 affected / 2186 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 84 affected / 2186 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 88 affected / 2186 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 87 affected / 2186 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 189 affected / 2186 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 106 affected / 2186 at risk

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 197 affected / 2186 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 253 affected / 2186 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 390 affected / 2186 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 231 affected / 2186 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 968 affected / 2186 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 339 affected / 2186 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 157 affected / 2186 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 447 affected / 2186 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 270 affected / 2186 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 310 affected / 2186 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 159 affected / 2186 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 227 affected / 2186 at risk

Adverse event: Pain - Breast
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 144 affected / 2186 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 137 affected / 2186 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 216 affected / 2186 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 133 affected / 2186 at risk

Adverse event: Hair loss/Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 120 affected / 2186 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 307 affected / 2186 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 97 affected / 2186 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 808 affected / 2186 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 127 affected / 2186 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 1530 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Cardiac General-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1530 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1530 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1530 at risk

Adverse event: SVT and nodal arrhythmia - Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1530 at risk

Adverse event: SVT and nodal arrhythmia - Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Ventricular arrhythmia - PVCs
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Ventricular arrhythmia - Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Ocular/Visual-Other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Gastrointestinal-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Hemorrhage, GI - Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1530 at risk

Adverse event: Obstruction, GI - Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1530 at risk

Adverse event: Death not associated with CTCAE term - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1530 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 1530 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1530 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1530 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1530 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Skin
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 1530 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1530 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils-Foreign bod
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1530 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutroph
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1530 at risk

Adverse event: Infection with unknown ANC - Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1530 at risk

Adverse event: Infection with unknown ANC - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1530 at risk

Adverse event: Infection with unknown ANC - Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1530 at risk

Adverse event: Infection with unknown ANC - Duodenum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1530 at risk

Adverse event: Infection with unknown ANC - Foreign body (e.g., g
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1530 at risk

Adverse event: Infection with unknown ANC - Heart (endocarditis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1530 at risk

Adverse event: Infection with unknown ANC - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1530 at risk

Adverse event: Infection with unknown ANC - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1530 at risk

Adverse event: Infection with unknown ANC - Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1530 at risk

Adverse event: Infection with unknown ANC - Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1530 at risk

Adverse event: Infection with unknown ANC - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1530 at risk

Adverse event: Infection-Other
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1530 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 1530 at risk

Adverse event: Intra-operative injury - Ovary
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1530 at risk

Adverse event: Leak (including anastomotic), GI - Leak NOS
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1530 at risk

Adverse event: Rash: dermatitis associated w/radiation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1530 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1530 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1530 at risk

Adverse event: Wound complication, non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1530 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1530 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1530 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1530 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1530 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1530 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1530 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Arthritis (non-septic)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Muscle weakness, not d/t neuropathy - body/general
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Musculoskeletal/Soft Tissue-Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 1530 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1530 at risk

Adverse event: Pain - Bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Death - Disease progression NOS
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1530 at risk

Adverse event: Pain - Tumor pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1530 at risk

Adverse event: Secondary Malignancy-poss rel to cancer Tx
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1530 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1530 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1530 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Neurology-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Neuropathy: CN VII Motor-face; Sensory-taste
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Ocular/Visual-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1530 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Hemorrhage, GU - Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Hemorrhage, GU - Urinary NOS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Obstruction, GU - Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Pain - Bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Pain - Kidney
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Renal/Genitourinary-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Sexual/Reproductive Function-Other
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 1530 at risk

Adverse event: Bronchospasm, wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 1530 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1530 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Dermatology/Skin-Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1530 at risk

Adverse event: Urticaria (hives, welts, wheals)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Phlebitis (including superficial thrombosis)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1530 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 1530 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 251 affected / 1530 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 180 affected / 1530 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 223 affected / 1530 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 280 affected / 1530 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 307 affected / 1530 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 100 affected / 1530 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 123 affected / 1530 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 163 affected / 1530 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 560 affected / 1530 at risk

Adverse event: Fever in absence of neutropenia, ANC lt1.0x10e9/L
Serious: no
Organ System: General disorders
Frequency: 70 affected / 1530 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 18 affected / 1530 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 122 affected / 1530 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 18 affected / 1530 at risk

Adverse event: Rash: dermatitis associated w/radiation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 70 affected / 1530 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 170 affected / 1530 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 190 affected / 1530 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 77 affected / 1530 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 127 affected / 1530 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 205 affected / 1530 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 125 affected / 1530 at risk

Adverse event: Metabolic/Laboratory-Other
Serious: no
Organ System: Investigations
Frequency: 67 affected / 1530 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 100 affected / 1530 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 51 affected / 1530 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 81 affected / 1530 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 61 affected / 1530 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 111 affected / 1530 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 283 affected / 1530 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 58 affected / 1530 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 82 affected / 1530 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 80 affected / 1530 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 88 affected / 1530 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 78 affected / 1530 at risk

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 143 affected / 1530 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 213 affected / 1530 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 303 affected / 1530 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 173 affected / 1530 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 756 affected / 1530 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 294 affected / 1530 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 134 affected / 1530 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 311 affected / 1530 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 205 affected / 1530 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 204 affected / 1530 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 106 affected / 1530 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 151 affected / 1530 at risk

Adverse event: Pain - Breast
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 102 affected / 1530 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 90 affected / 1530 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 143 affected / 1530 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 116 affected / 1530 at risk

Adverse event: Hair loss/Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 90 affected / 1530 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 194 affected / 1530 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 79 affected / 1530 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 579 affected / 1530 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 60 affected / 1530 at risk