Study: NCT00553410

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Cardiac Arrhythmia-Other (Specify)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 2411 at risk

Adverse event: Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 2411 at risk

Adverse event: Pain - Cardiac/heart
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Restrictive cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Right ventricular dysfunction (cor pulmonale)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Supraventricular and nodal arrhythmia - Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 2411 at risk

Adverse event: Supraventricular and nodal arrhythmia - Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2411 at risk

Adverse event: Supraventricular and nodal arrhythmia - Atrial tachycardia/paroxysmal atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Supraventricular and nodal arrhythmia - Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 2411 at risk

Adverse event: Ventricular arrhythmia - Ventricular arrhythmia NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Ventricular arrhythmia - Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Auditory/Ear-Other (Specify)
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 2411 at risk

Adverse event: Endocrine-Other (Specify)
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 2411 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 8 affected / 2411 at risk

Adverse event: Dry eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Ocular/Visual-Other (Specify)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Ophthalmoplegia/diplopia (double vision)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Vision-blurred vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Vision-photophobia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Obstruction, GI - Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Obstruction, GI - Ileum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Obstruction, GI - Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 2411 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 2411 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Gastrointestinal-Other (Specify)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 2411 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 2411 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 2411 at risk

Adverse event: Pain - Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 58 affected / 2411 at risk

Adverse event: Death not associated with CTCAE term - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Death not associated with CTCAE term - Sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Pain - Pain NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Pain-Other (Specify)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Obstruction, GI - Gallbladder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Stricture/stenosis (including anastomotic), GI - Biliary tree
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 2411 at risk

Adverse event: Hepatobiliary/Pancreas-Other (Specify)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 2411 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 5 affected / 2411 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2411 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Brain (encephalitis, infectious)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2411 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: 3 affected / 2411 at risk

Adverse event: Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2411 at risk

Adverse event: Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Small bowel NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2411 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Pharynx
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2411 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2411 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 2411 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2411 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Brain + Spinal cord (encephalomyelitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2411 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 / 2411 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2411 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2411 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Gallbladder (cholecystitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2411 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 / 2411 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 / 2411 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 2411 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 / 2411 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 / 2411 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 / 2411 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: 3 affected / 2411 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 2411 at risk

Adverse event: Infection with unknown ANC - Dental-tooth
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2411 at risk

Adverse event: Infection with unknown ANC - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 2411 at risk

Adverse event: Infection with unknown ANC - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 2411 at risk

Adverse event: Infection with unknown ANC - Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2411 at risk

Adverse event: Infection with unknown ANC - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2411 at risk

Adverse event: Infection-Other (Specify)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2411 at risk

Adverse event: Wound complication, non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2411 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 66 affected / 2411 at risk

Adverse event: Intra-operative injury - Oral
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2411 at risk

Adverse event: Intra-operative injury - Spleen
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2411 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2411 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 2411 at risk

Adverse event: Vessel injury-artery - Carotid
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2411 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 2411 at risk

Adverse event: GGT (gamma-glutamyl transpeptidase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2411 at risk

Adverse event: Metabolic/Laboratory-Other (Specify)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2411 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 2411 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2411 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2411 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 2411 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 2411 at risk

Adverse event: Arthritis (non-septic)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 2411 at risk

Adverse event: Joint-function
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 2411 at risk

Adverse event: Musculoskeletal/Soft Tissue-Other (Specify)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 2411 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 2411 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 2411 at risk

Adverse event: Pain - Bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 58 affected / 2411 at risk

Adverse event: Pain - Chest wall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Pain - Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Pain - Joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 151 affected / 2411 at risk

Adverse event: Pain - Muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 54 affected / 2411 at risk

Adverse event: Pain - Neck
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Soft tissue necrosis - Extremity-lower
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 2411 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2411 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 31 affected / 2411 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 2411 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Mental status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Myelitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Neurology-Other (Specify)
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 2411 at risk

Adverse event: Neuropathy: cranial - CN VII Motor-face; Sensory-taste
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Neuropathy: cranial - CN VIII Hearing and balance
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 2411 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 2411 at risk

Adverse event: Pain - Neuralgia/peripheral nerve
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 2411 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 2411 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 59 affected / 2411 at risk

Adverse event: Mood alteration - anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 54 affected / 2411 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Hemorrhage, GU - Urinary NOS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Incontinence, urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Obstruction, GU - Urethra
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 2411 at risk

Adverse event: Renal/Genitourinary-Other (Specify)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 2411 at risk

Adverse event: Hemorrhage, GU - Vagina
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Pain - Pelvis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Sexual/Reproductive Function-Other (Specify)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 2411 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 2411 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Obstruction/stenosis of airway - Bronchus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2411 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Pulmonary/Upper Respiratory-Other (Specify)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 2411 at risk

Adverse event: Urticaria (hives, welts, wheals)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Dermatology/Skin-Other (Specify)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 2411 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2411 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 2411 at risk

Adverse event: Hot flashes/flushes
Serious: yes
Organ System: Vascular disorders
Frequency: 70 affected / 2411 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 517 affected / 2411 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2411 at risk

Adverse event: Vascular-Other (Specify)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2411 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 2411 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 1025 affected / 2411 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 148 affected / 2411 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 2411 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1113 affected / 2411 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 634 affected / 2411 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1506 affected / 2411 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 841 affected / 2411 at risk

Adverse event: Hemorrhage, CNS
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 2411 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 2411 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 983 affected / 2411 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 767 affected / 2411 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 1240 affected / 2411 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 539 affected / 2411 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Cardiac Arrhythmia-Other (Specify)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 2417 at risk

Adverse event: Conduction abnormality/Atrioventricular heart block - AV block-2nd degree Mobitz Type I (Wenckebach)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Conduction abnormality/Atrioventricular heart block - Wolff-Parkinson-White syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2417 at risk

Adverse event: Restrictive cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Right ventricular dysfunction (cor pulmonale)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Supraventricular and nodal arrhythmia - Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 2417 at risk

Adverse event: Supraventricular and nodal arrhythmia - Atrial tachycardia/paroxysmal atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Supraventricular and nodal arrhythmia - Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 2417 at risk

Adverse event: Ventricular arrhythmia - Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Auditory/Ear-Other (Specify)
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 2417 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 / 2417 at risk

Adverse event: Thyroid function, high (hyperthyroidism, thyrotoxicosis)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Endocrine-Other (Specify)
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 10 affected / 2417 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Ocular/Visual-Other (Specify)
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 2417 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Vision-blurred vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Hemorrhage, GI - Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Hemorrhage, GI - Upper GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Obstruction, GI - Cecum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Ulcer, GI - Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 2417 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Dental: teeth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 2417 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Gastrointestinal-Other (Specify)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 2417 at risk

Adverse event: Heartburn/dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Anus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 2417 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 48 affected / 2417 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 / 2417 at risk

Adverse event: Constitutional Symptoms-Other (Specify)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Death not associated with CTCAE term - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Pain-Other (Specify)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 2417 at risk

Adverse event: Obstruction, GI - Gallbladder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 13 affected / 2417 at risk

Adverse event: Hepatobiliary/Pancreas-Other (Specify)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 2417 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 2417 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: 3 affected / 2417 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 / 2417 at risk

Adverse event: Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2417 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2417 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Paranasal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2417 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 / 2417 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 / 2417 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Bone (osteomyelitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 2417 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 / 2417 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2417 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 2417 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Gallbladder (cholecystitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2417 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 / 2417 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 2417 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Lymphatic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2417 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 / 2417 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 / 2417 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 / 2417 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 / 2417 at risk

Adverse event: Infection with unknown ANC - Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2417 at risk

Adverse event: Infection with unknown ANC - Larynx
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2417 at risk

Adverse event: Infection with unknown ANC - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 2417 at risk

Adverse event: Infection with unknown ANC - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2417 at risk

Adverse event: Infection with unknown ANC - Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2417 at risk

Adverse event: Infection with unknown ANC - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2417 at risk

Adverse event: Infection-Other (Specify)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 2417 at risk

Adverse event: Hepatitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2417 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 62 affected / 2417 at risk

Adverse event: Intra-operative injury - Joint
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2417 at risk

Adverse event: Local complication - device/prosthesis-related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2417 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 2417 at risk

Adverse event: Vessel injury-artery - Aorta
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2417 at risk

Adverse event: Cholesterol, serum-high (hypercholesterolemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2417 at risk

Adverse event: Coagulation-Other (Specify)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2417 at risk

Adverse event: INR (International Normalized Ratio of prothrombin time)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2417 at risk

Adverse event: Lipase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2417 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 2417 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2417 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 2417 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 2417 at risk

Adverse event: Arthritis (non-septic)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 2417 at risk

Adverse event: Fibrosis-deep connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Joint-function
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 2417 at risk

Adverse event: Lymphedema-related fibrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Musculoskeletal/Soft Tissue-Other (Specify)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 2417 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 2417 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 2417 at risk

Adverse event: Pain - Bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 46 affected / 2417 at risk

Adverse event: Pain - Chest wall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Pain - Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 2417 at risk

Adverse event: Pain - Joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 139 affected / 2417 at risk

Adverse event: Pain - Muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 2417 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 2417 at risk

Adverse event: Speech impairment (e.g., dysphasia or aphasia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2417 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 24 affected / 2417 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 2417 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 2417 at risk

Adverse event: Neurology-Other (Specify)
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 2417 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 2417 at risk

Adverse event: Pain - Neuralgia/peripheral nerve
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 2417 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 2417 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 52 affected / 2417 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 61 affected / 2417 at risk

Adverse event: Incontinence, urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Obstruction, GU - Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 2417 at risk

Adverse event: Renal/Genitourinary-Other (Specify)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 2417 at risk

Adverse event: Sexual/Reproductive Function-Other (Specify)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 2417 at risk

Adverse event: Adult respiratory distress syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 2417 at risk

Adverse event: Obstruction/stenosis of airway - Bronchus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2417 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Pulmonary/Upper Respiratory-Other (Specify)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 2417 at risk

Adverse event: Dermatology/Skin-Other (Specify)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 2417 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Hemorrhage/Bleeding-Other (Specify)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2417 at risk

Adverse event: Hot flashes/flushes
Serious: yes
Organ System: Vascular disorders
Frequency: 59 affected / 2417 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 584 affected / 2417 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Vascular-Other (Specify)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2417 at risk

Adverse event: Vasculitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2417 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 2417 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 954 affected / 2417 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 136 affected / 2417 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 2417 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1119 affected / 2417 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 613 affected / 2417 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1453 affected / 2417 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 818 affected / 2417 at risk

Adverse event: Hemorrhage, CNS
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 2417 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 2417 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 961 affected / 2417 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 762 affected / 2417 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 1217 affected / 2417 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 493 affected / 2417 at risk