Study: NCT00066703

Adverse event: Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura or hemolytic uremic syndrome)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1321 at risk

Adverse event: Cardiac Arrhythmia-Other (Specify)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1321 at risk

Adverse event: Supraventricular and nodal arrhythmia - Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Supraventricular and nodal arrhythmia - Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Auditory/Ear-Other (Specify)
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Thyroid function, high (hyperthyroidism, thyrotoxicosis)
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Endocrine-Other (Specify)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Hemorrhage, GI - Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Hemorrhage, GI - Varices (rectal)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Perforation, GI - Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Stricture/stenosis (including anastomotic), GI - Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1321 at risk

Adverse event: Gastrointestinal-Other (Specify)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 1321 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1321 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 32 affected / 1321 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Death not associated with CTCAE term - Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Flu-like syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Pain-Other (Specify)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Obstruction, GI - Gallbladder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 1321 at risk

Adverse event: Hepatobiliary/Pancreas-Other (Specify)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 1321 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 1321 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 7 affected / 1321 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body (e.g., graft, implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1321 at risk

Adverse event: Infection with unknown ANC - Foreign body (e.g., graft, implant, prosthesis, stent)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1321 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1321 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1321 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1321 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Nerve-peripheral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1321 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1321 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1321 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Small bowel NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1321 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Stomach
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1321 at risk

Adverse event: Infection with unknown ANC - Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1321 at risk

Adverse event: Infection with unknown ANC - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1321 at risk

Adverse event: Infection with unknown ANC - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1321 at risk

Adverse event: Infection-Other (Specify)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1321 at risk

Adverse event: Wound complication, non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1321 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 1321 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 29 affected / 1321 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 1321 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 1321 at risk

Adverse event: Carbon monoxide diffusion capacity (DL(co))
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1321 at risk

Adverse event: GGT (gamma-glutamyl transpeptidase)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1321 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1321 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1321 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 1321 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 1321 at risk

Adverse event: Joint-function
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Musculoskeletal/Soft Tissue-Other (Specify)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1321 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 1321 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Pain - Bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Pain - Chest wall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Pain - Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Pain - Joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 69 affected / 1321 at risk

Adverse event: Pain - Neck
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1321 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 1321 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Neurology-Other (Specify)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Neuropathy: cranial - CN V Motor-jaw muscles; Sensory-facial
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 1321 at risk

Adverse event: Pain - Neuralgia/peripheral nerve
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 54 affected / 1321 at risk

Adverse event: Mood alteration - anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 59 affected / 1321 at risk

Adverse event: Incontinence, urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1321 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Renal/Genitourinary-Other (Specify)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 24 affected / 1321 at risk

Adverse event: Hemorrhage, GU - Vagina
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 1321 at risk

Adverse event: Pain - Vagina
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 1321 at risk

Adverse event: Sexual/Reproductive Function-Other (Specify)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1321 at risk

Adverse event: Bronchospasm, wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Obstruction/stenosis of airway - Larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Pulmonary/Upper Respiratory-Other (Specify)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Hot flashes/flushes
Serious: yes
Organ System: Vascular disorders
Frequency: 149 affected / 1321 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 100 affected / 1321 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Vascular-Other (Specify)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1321 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 446 affected / 1321 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 807 affected / 1321 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: General disorders
Frequency: 99 affected / 1321 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 56 affected / 1321 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 57 affected / 1321 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1321 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 1321 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 1321 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 388 affected / 1321 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 953 affected / 1321 at risk

Adverse event: Hemorrhage, CNS
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 1321 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1321 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 738 affected / 1321 at risk

Adverse event: Libido
Serious: no
Organ System: Psychiatric disorders
Frequency: 486 affected / 1321 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 592 affected / 1321 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 232 affected / 1321 at risk

Adverse event: Pain - Vagina
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 336 affected / 1321 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 611 affected / 1321 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 752 affected / 1321 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 1081 affected / 1321 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 179 affected / 1321 at risk

Adverse event: Blood/Bone Marrow-Other (Specify)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1317 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1317 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Pain - Cardiac/heart
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Supraventricular and nodal arrhythmia - Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1317 at risk

Adverse event: Supraventricular and nodal arrhythmia - Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Auditory/Ear-Other (Specify)
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Endocrine-Other (Specify)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Hemorrhage, GI - Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Obstruction, GI - Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Ulcer, GI - Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1317 at risk

Adverse event: Gastrointestinal-Other (Specify)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1317 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 1317 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1317 at risk

Adverse event: Pain - Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1317 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 41 affected / 1317 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1317 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Hepatobiliary/Pancreas-Other (Specify)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Pain - Gallbladder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 5 affected / 1317 at risk

Adverse event: Allergy/Immunology-Other (Specify)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1317 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Joint
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Middle ear (otitis media)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Pelvis NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Salivary gland
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Soft tissue NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1317 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1317 at risk

Adverse event: Infection with unknown ANC - Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1317 at risk

Adverse event: Infection with unknown ANC - Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1317 at risk

Adverse event: Infection with unknown ANC - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1317 at risk

Adverse event: Infection-Other (Specify)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1317 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 1317 at risk

Adverse event: Intra-operative injury - Ureter
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1317 at risk

Adverse event: Intra-operative injury - Vagina
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1317 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 1317 at risk

Adverse event: Vessel injury-vein - Extremity-upper
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1317 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1317 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 1317 at risk

Adverse event: Cholesterol, serum-high (hypercholesterolemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1317 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1317 at risk

Adverse event: GGT (gamma-glutamyl transpeptidase)
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 1317 at risk

Adverse event: INR (International Normalized Ratio of prothrombin time)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1317 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1317 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1317 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1317 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 1317 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 1317 at risk

Adverse event: Extremity-upper (function)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Joint-function
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Lymphedema-related fibrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Musculoskeletal/Soft Tissue-Other (Specify)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 1317 at risk

Adverse event: Pain - Bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Pain - Chest wall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Pain - Joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 139 affected / 1317 at risk

Adverse event: Pain - Neck
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Secondary Malignancy-possibly related to cancer treatment (Specify)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1317 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1317 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1317 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1317 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Neurology-Other (Specify)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1317 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1317 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 1317 at risk

Adverse event: Pain - Neuralgia/peripheral nerve
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 1317 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1317 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 44 affected / 1317 at risk

Adverse event: Mood alteration - anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1317 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 51 affected / 1317 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Incontinence, urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1317 at risk

Adverse event: Obstruction, GU - Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Renal/Genitourinary-Other (Specify)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 1317 at risk

Adverse event: Hemorrhage, GU - Uterus
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Hemorrhage, GU - Vagina
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Breast nipple/areolar deformity
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Irregular menses (change from baseline)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Pain - Vagina
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 33 affected / 1317 at risk

Adverse event: Sexual/Reproductive Function-Other (Specify)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1317 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Pulmonary/Upper Respiratory-Other (Specify)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1317 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Hot flashes/flushes
Serious: yes
Organ System: Vascular disorders
Frequency: 127 affected / 1317 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 90 affected / 1317 at risk

Adverse event: Vasculitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1317 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 478 affected / 1317 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 760 affected / 1317 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: General disorders
Frequency: 86 affected / 1317 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 60 affected / 1317 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 82 affected / 1317 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1317 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 1317 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 1317 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 588 affected / 1317 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1030 affected / 1317 at risk

Adverse event: Hemorrhage, CNS
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 1317 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1317 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 714 affected / 1317 at risk

Adverse event: Libido
Serious: no
Organ System: Psychiatric disorders
Frequency: 555 affected / 1317 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 610 affected / 1317 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 182 affected / 1317 at risk

Adverse event: Pain - Vagina
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 374 affected / 1317 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 683 affected / 1317 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 705 affected / 1317 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 1076 affected / 1317 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 213 affected / 1317 at risk