Study: NCT00066690

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1007 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Auditory/Ear-Other (Specify)
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Hearing: patients without baseline audiogram and not enrolled in a monitoring program
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Endocrine-Other (Specify)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Ocular/Visual-Other (Specify)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 1007 at risk

Adverse event: Obstruction, GI - Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Ulcer, GI - Anus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Gastrointestinal-Other (Specify)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1007 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 32 affected / 1007 at risk

Adverse event: Death not associated with CTCAE term - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Pain-Other (Specify)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Hepatobiliary/Pancreas-Other (Specify)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1007 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1007 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: 1 affected / 1007 at risk

Adverse event: Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1007 at risk

Adverse event: Infection (documented clinically/microbiologically) w/Grade 3/4 neutrophils -Gallbladder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1007 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 / 1007 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1007 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 / 1007 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1007 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Vagina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1007 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1007 at risk

Adverse event: Infection with unknown ANC - Heart (endocarditis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1007 at risk

Adverse event: Infection with unknown ANC - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1007 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 1007 at risk

Adverse event: Intra-operative injury - Vein NOS
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1007 at risk

Adverse event: Rash: dermatitis associated with radiation - Radiation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1007 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 1007 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1007 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1007 at risk

Adverse event: GGT (gamma-glutamyl transpeptidase)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1007 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1007 at risk

Adverse event: Arthritis (non-septic)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Musculoskeletal/Soft Tissue-Other (Specify)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pain - Chest wall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pain - Joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 64 affected / 1007 at risk

Adverse event: Pain - Muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1007 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1007 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1007 at risk

Adverse event: Neurology-Other (Specify)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Neuropathy: cranial - CN V Motor-jaw muscles; Sensory-facial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 1007 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 29 affected / 1007 at risk

Adverse event: Mood alteration - anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 38 affected / 1007 at risk

Adverse event: Incontinence, urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 1007 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Renal/Genitourinary-Other (Specify)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 49 affected / 1007 at risk

Adverse event: Hemorrhage, GU - Ovary
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Hemorrhage, GU - Uterus
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 1007 at risk

Adverse event: Hemorrhage, GU - Vagina
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 1007 at risk

Adverse event: Stricture/stenosis (including anastomotic), GU - Uterus
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Irregular menses (change from baseline)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 1007 at risk

Adverse event: Pain - Breast
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Pain - Ovulatory
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pain - Pelvis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pain - Vagina
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 1007 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Dermatology/Skin-Other (Specify)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Hot flashes/flushes
Serious: yes
Organ System: Vascular disorders
Frequency: 76 affected / 1007 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 54 affected / 1007 at risk

Adverse event: Vascular-Other (Specify)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 239 affected / 1007 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 571 affected / 1007 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1007 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 31 affected / 1007 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 41 affected / 1007 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1007 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 1007 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 1007 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 123 affected / 1007 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 631 affected / 1007 at risk

Adverse event: Hemorrhage, CNS
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 1007 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 437 affected / 1007 at risk

Adverse event: Libido
Serious: no
Organ System: Psychiatric disorders
Frequency: 427 affected / 1007 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 431 affected / 1007 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 156 affected / 1007 at risk

Adverse event: Pain - Vagina
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 224 affected / 1007 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 421 affected / 1007 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 486 affected / 1007 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 727 affected / 1007 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 119 affected / 1007 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Cardiac Arrhythmia-Other (Specify)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Supraventricular and nodal arrhythmia - Sinus arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Supraventricular and nodal arrhythmia - Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Thyroid function, high (hyperthyroidism, thyrotoxicosis)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Distention/bloating, abdominal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Necrosis, GI - Ileum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Gastrointestinal-Other (Specify)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Heartburn/dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) - Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1007 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1007 at risk

Adverse event: Pain - Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 36 affected / 1007 at risk

Adverse event: Flu-like syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Hepatobiliary/Pancreas-Other (Specify)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 1007 at risk

Adverse event: Pain - Gallbladder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Allergy/Immunology-Other (Specify)
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 1007 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: 2 affected / 1007 at risk

Adverse event: Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1007 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 / 1007 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1007 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 / 1007 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1007 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 1007 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: 1 affected / 1007 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 / 1007 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1007 at risk

Adverse event: Infection with unknown ANC - Rectum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1007 at risk

Adverse event: Infection with unknown ANC - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1007 at risk

Adverse event: Infection-Other (Specify)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1007 at risk

Adverse event: Wound complication, non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1007 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 1007 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 1007 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1007 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1007 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1007 at risk

Adverse event: GGT (gamma-glutamyl transpeptidase)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1007 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1007 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1007 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 1007 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Iron overload
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 1007 at risk

Adverse event: Lumbar spine-range of motion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Musculoskeletal/Soft Tissue-Other (Specify)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Myositis (inflammation/damage of muscle)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1007 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pain - Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pain - Joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 1007 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1007 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Neurology-Other (Specify)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Neuropathy: cranial - CN VIII Hearing and balance
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1007 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 1007 at risk

Adverse event: Pain - Neuralgia/peripheral nerve
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 46 affected / 1007 at risk

Adverse event: Mood alteration - anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 44 affected / 1007 at risk

Adverse event: Incontinence, urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 1007 at risk

Adverse event: Obstruction, GU - Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Renal/Genitourinary-Other (Specify)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 19 affected / 1007 at risk

Adverse event: Hemorrhage, GU - Uterus
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Hemorrhage, GU - Vagina
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Irregular menses (change from baseline)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Pain - Ovulatory
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pain - Vagina
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 22 affected / 1007 at risk

Adverse event: Sexual/Reproductive Function-Other (Specify)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pain - Pleura
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Dermatology/Skin-Other (Specify)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pain - Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1007 at risk

Adverse event: Soft tissue necrosis - Thorax
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Hot flashes/flushes
Serious: yes
Organ System: Vascular disorders
Frequency: 133 affected / 1007 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 75 affected / 1007 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1007 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 215 affected / 1007 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 595 affected / 1007 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: General disorders
Frequency: 88 affected / 1007 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 42 affected / 1007 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 46 affected / 1007 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1007 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 1007 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 1007 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 198 affected / 1007 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 700 affected / 1007 at risk

Adverse event: Hemorrhage, CNS
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 1007 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1007 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 529 affected / 1007 at risk

Adverse event: Libido
Serious: no
Organ System: Psychiatric disorders
Frequency: 477 affected / 1007 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 478 affected / 1007 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 180 affected / 1007 at risk

Adverse event: Pain - Vagina
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 240 affected / 1007 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 500 affected / 1007 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 621 affected / 1007 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 806 affected / 1007 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 158 affected / 1007 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1001 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1001 at risk

Adverse event: Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Conduction abnormality/Atrioventricular heart block - Sick sinus syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1001 at risk

Adverse event: Pain - Cardiac/heart
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Restrictive cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Right ventricular dysfunction (cor pulmonale)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Supraventricular and nodal arrhythmia - Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Hearing: patients without baseline audiogram and not enrolled in a monitoring program
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Thyroid function, high (hyperthyroidism, thyrotoxicosis)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Optic disc edema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Vision-flashing lights/floaters
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Stricture/stenosis (including anastomotic), GI - Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Gastrointestinal-Other (Specify)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1001 at risk

Adverse event: Heartburn/dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1001 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1001 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 33 affected / 1001 at risk

Adverse event: Death not associated with CTCAE term - Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1001 at risk

Adverse event: Pain-Other (Specify)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1001 at risk

Adverse event: Hepatobiliary/Pancreas-Other (Specify)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 1001 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 6 affected / 1001 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: 1 affected / 1001 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1001 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 / 1001 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1001 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 / 1001 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 / 1001 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 1001 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: 2 affected / 1001 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1001 at risk

Adverse event: Infection with unknown ANC - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1001 at risk

Adverse event: Infection with unknown ANC - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1001 at risk

Adverse event: Infection-Other (Specify)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1001 at risk

Adverse event: Hemorrhage/bleeding associated with surgery, intra-operative or post-operative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1001 at risk

Adverse event: Wound complication, non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1001 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 1001 at risk

Adverse event: Rash: dermatitis associated with radiation - Radiation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1001 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 1001 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1001 at risk

Adverse event: GGT (gamma-glutamyl transpeptidase)
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 1001 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1001 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 1001 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1001 at risk

Adverse event: Musculoskeletal/Soft Tissue-Other (Specify)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1001 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1001 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Pain - Chest wall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Pain - Joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 119 affected / 1001 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1001 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1001 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Myelitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Neurology-Other (Specify)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1001 at risk

Adverse event: Neuropathy: cranial - CN VIII Hearing and balance
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1001 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 1001 at risk

Adverse event: Pain - Neuralgia/peripheral nerve
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 1001 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1001 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 45 affected / 1001 at risk

Adverse event: Mood alteration - anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 37 affected / 1001 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Incontinence, urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1001 at risk

Adverse event: Obstruction, GU - Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1001 at risk

Adverse event: Stricture/stenosis (including anastomotic), GU - Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Renal/Genitourinary-Other (Specify)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 1001 at risk

Adverse event: Hemorrhage, GU - Uterus
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1001 at risk

Adverse event: Hemorrhage, GU - Vagina
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Pain - Breast
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Pain - Vagina
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 19 affected / 1001 at risk

Adverse event: Sexual/Reproductive Function-Other (Specify)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1001 at risk

Adverse event: Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1001 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1001 at risk

Adverse event: Obstruction/stenosis of airway - Bronchus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1001 at risk

Adverse event: Hot flashes/flushes
Serious: yes
Organ System: Vascular disorders
Frequency: 107 affected / 1001 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 68 affected / 1001 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1001 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 228 affected / 1001 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 591 affected / 1001 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: General disorders
Frequency: 84 affected / 1001 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 46 affected / 1001 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 51 affected / 1001 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1001 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 1001 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 1001 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 316 affected / 1001 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 778 affected / 1001 at risk

Adverse event: Hemorrhage, CNS
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 1001 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 549 affected / 1001 at risk

Adverse event: Libido
Serious: no
Organ System: Psychiatric disorders
Frequency: 492 affected / 1001 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 476 affected / 1001 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 120 affected / 1001 at risk

Adverse event: Pain - Vagina
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 290 affected / 1001 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 541 affected / 1001 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 566 affected / 1001 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 820 affected / 1001 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 165 affected / 1001 at risk