Time Frame |
[Not Specified]
|
Adverse Event Reporting Description |
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Arm/Group Title
|
Tamoxifen Followed by Exemestane
|
Exemestane
|
Arm/Group Description |
Tamoxifen 20 mg QD; upon completing...
|
Exemestane (Aromasin®) 25 mg QD for...
|
Arm/Group Description |
Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
|
Exemestane (Aromasin®) 25 mg QD for 5 years
|
|
|
Tamoxifen Followed by Exemestane
|
Exemestane
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
|
|
Tamoxifen Followed by Exemestane
|
Exemestane
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
784/4814 (16.29%) |
831/4852 (17.13%) |
Blood and lymphatic system disorders |
|
|
Anaemia |
5/4814 (0.10%) |
12/4852 (0.25%) |
Anaemia vitamin B12 deficiency |
1/4814 (0.02%) |
0/4852 (0.00%) |
Coagulopathy |
1/4814 (0.02%) |
0/4852 (0.00%) |
Febrile neutropenia |
0/4814 (0.00%) |
2/4852 (0.04%) |
Haemorrhagic anaemia |
0/4814 (0.00%) |
1/4852 (0.02%) |
Iron deficiency anaemia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Leukocytosis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Leukopenia |
1/4814 (0.02%) |
1/4852 (0.02%) |
Lymphadenopathy |
1/4814 (0.02%) |
3/4852 (0.06%) |
Neutropenia |
0/4814 (0.00%) |
1/4852 (0.02%) |
Pancytopenia |
0/4814 (0.00%) |
2/4852 (0.04%) |
Thrombocytopenia |
0/4814 (0.00%) |
1/4852 (0.02%) |
Cardiac disorders |
|
|
Acute coronary syndrome |
1/4814 (0.02%) |
0/4852 (0.00%) |
Acute myocardial infarction |
1/4814 (0.02%) |
0/4852 (0.00%) |
Angina pectoris |
7/4814 (0.15%) |
8/4852 (0.16%) |
Angina unstable |
0/4814 (0.00%) |
2/4852 (0.04%) |
Aortic valve incompetence |
0/4814 (0.00%) |
1/4852 (0.02%) |
Aortic valve stenosis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Arrhythmia |
0/4814 (0.00%) |
4/4852 (0.08%) |
Arrhythmia supraventricular |
0/4814 (0.00%) |
1/4852 (0.02%) |
Atrial fibrillation |
15/4814 (0.31%) |
18/4852 (0.37%) |
Atrial flutter |
1/4814 (0.02%) |
2/4852 (0.04%) |
Atrial tachycardia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Atrioventricular block |
2/4814 (0.04%) |
0/4852 (0.00%) |
Atrioventricular block complete |
0/4814 (0.00%) |
1/4852 (0.02%) |
Bradycardia |
1/4814 (0.02%) |
4/4852 (0.08%) |
Cardiac arrest |
0/4814 (0.00%) |
1/4852 (0.02%) |
Cardiac asthma |
0/4814 (0.00%) |
1/4852 (0.02%) |
Cardiac disorder |
1/4814 (0.02%) |
1/4852 (0.02%) |
Cardiac failure |
7/4814 (0.15%) |
9/4852 (0.19%) |
Cardiac failure congestive |
6/4814 (0.12%) |
12/4852 (0.25%) |
Cardiac valve disease |
0/4814 (0.00%) |
1/4852 (0.02%) |
Cardiomyopathy |
2/4814 (0.04%) |
1/4852 (0.02%) |
Cardiopulmonary failure |
0/4814 (0.00%) |
1/4852 (0.02%) |
Cardiovascular disorder |
0/4814 (0.00%) |
2/4852 (0.04%) |
Congestive cardiomyopathy |
1/4814 (0.02%) |
1/4852 (0.02%) |
Cor pulmonale |
1/4814 (0.02%) |
2/4852 (0.04%) |
Coronary artery disease |
7/4814 (0.15%) |
8/4852 (0.16%) |
Coronary artery insufficiency |
1/4814 (0.02%) |
0/4852 (0.00%) |
Coronary artery occlusion |
0/4814 (0.00%) |
1/4852 (0.02%) |
Coronary artery stenosis |
1/4814 (0.02%) |
1/4852 (0.02%) |
Cytotoxic cardiomyopathy |
0/4814 (0.00%) |
1/4852 (0.02%) |
Intracardiac thrombus |
0/4814 (0.00%) |
1/4852 (0.02%) |
Left ventricular failure |
0/4814 (0.00%) |
4/4852 (0.08%) |
Mitral valve incompetence |
1/4814 (0.02%) |
2/4852 (0.04%) |
Myocardial infarction |
18/4814 (0.37%) |
18/4852 (0.37%) |
Myocardial ischaemia |
1/4814 (0.02%) |
4/4852 (0.08%) |
Palpitations |
2/4814 (0.04%) |
0/4852 (0.00%) |
Pericardial effusion |
0/4814 (0.00%) |
5/4852 (0.10%) |
Pleuropericarditis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Prinzmetal angina |
0/4814 (0.00%) |
1/4852 (0.02%) |
Right ventricular failure |
0/4814 (0.00%) |
1/4852 (0.02%) |
Sick sinus syndrome |
1/4814 (0.02%) |
1/4852 (0.02%) |
Sinus bradycardia |
0/4814 (0.00%) |
1/4852 (0.02%) |
Sinus tachycardia |
0/4814 (0.00%) |
2/4852 (0.04%) |
Supraventricular tachycardia |
1/4814 (0.02%) |
2/4852 (0.04%) |
Tachyarrhythmia |
0/4814 (0.00%) |
3/4852 (0.06%) |
Tachycardia |
4/4814 (0.08%) |
1/4852 (0.02%) |
Ventricular fibrillation |
1/4814 (0.02%) |
0/4852 (0.00%) |
Ventricular tachycardia |
1/4814 (0.02%) |
1/4852 (0.02%) |
Congenital, familial and genetic disorders |
|
|
Adenomatous polyposis coli |
0/4814 (0.00%) |
1/4852 (0.02%) |
Congenital musculoskeletal anomaly |
0/4814 (0.00%) |
2/4852 (0.04%) |
Dermoid cyst |
0/4814 (0.00%) |
1/4852 (0.02%) |
Skull malformation |
1/4814 (0.02%) |
0/4852 (0.00%) |
Spine malformation |
3/4814 (0.06%) |
0/4852 (0.00%) |
Ear and labyrinth disorders |
|
|
Deafness unilateral |
0/4814 (0.00%) |
1/4852 (0.02%) |
Otosclerosis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Tinnitus |
0/4814 (0.00%) |
2/4852 (0.04%) |
Tympanic membrane disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Vertigo |
7/4814 (0.15%) |
1/4852 (0.02%) |
Endocrine disorders |
|
|
Goitre |
3/4814 (0.06%) |
6/4852 (0.12%) |
Hyperparathyroidism |
1/4814 (0.02%) |
1/4852 (0.02%) |
Hyperthyroidism |
0/4814 (0.00%) |
1/4852 (0.02%) |
Hypothyroidism |
0/4814 (0.00%) |
1/4852 (0.02%) |
Thyroid disorder |
1/4814 (0.02%) |
0/4852 (0.00%) |
Thyroiditis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Toxic nodular goitre |
1/4814 (0.02%) |
1/4852 (0.02%) |
Eye disorders |
|
|
Cataract |
2/4814 (0.04%) |
3/4852 (0.06%) |
Eye disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Eye pain |
0/4814 (0.00%) |
1/4852 (0.02%) |
Glaucoma |
2/4814 (0.04%) |
1/4852 (0.02%) |
Retinal detachment |
0/4814 (0.00%) |
3/4852 (0.06%) |
Retinal disorder |
1/4814 (0.02%) |
0/4852 (0.00%) |
Retinal haemorrhage |
0/4814 (0.00%) |
1/4852 (0.02%) |
Retinal ischaemia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Retinal vein occlusion |
0/4814 (0.00%) |
1/4852 (0.02%) |
Visual acuity reduced |
1/4814 (0.02%) |
0/4852 (0.00%) |
Visual impairment |
0/4814 (0.00%) |
1/4852 (0.02%) |
Vitreous detachment |
1/4814 (0.02%) |
0/4852 (0.00%) |
Gastrointestinal disorders |
|
|
Abdominal distension |
0/4814 (0.00%) |
2/4852 (0.04%) |
Abdominal hernia |
0/4814 (0.00%) |
3/4852 (0.06%) |
Abdominal pain |
11/4814 (0.23%) |
14/4852 (0.29%) |
Abdominal pain lower |
0/4814 (0.00%) |
2/4852 (0.04%) |
Abdominal pain upper |
2/4814 (0.04%) |
2/4852 (0.04%) |
Acute abdomen |
1/4814 (0.02%) |
0/4852 (0.00%) |
Anal fissure |
1/4814 (0.02%) |
1/4852 (0.02%) |
Anal prolapse |
0/4814 (0.00%) |
1/4852 (0.02%) |
Ascites |
2/4814 (0.04%) |
0/4852 (0.00%) |
Colitis |
0/4814 (0.00%) |
3/4852 (0.06%) |
Colonic polyp |
0/4814 (0.00%) |
1/4852 (0.02%) |
Constipation |
1/4814 (0.02%) |
0/4852 (0.00%) |
Crohn's disease |
0/4814 (0.00%) |
1/4852 (0.02%) |
Diarrhoea |
7/4814 (0.15%) |
10/4852 (0.21%) |
Diarrhoea haemorrhagic |
1/4814 (0.02%) |
0/4852 (0.00%) |
Diverticulum |
0/4814 (0.00%) |
2/4852 (0.04%) |
Diverticulum intestinal |
1/4814 (0.02%) |
1/4852 (0.02%) |
Duodenal ulcer haemorrhage |
0/4814 (0.00%) |
2/4852 (0.04%) |
Enteritis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Enterocolitis haemorrhagic |
1/4814 (0.02%) |
0/4852 (0.00%) |
Epigastric discomfort |
1/4814 (0.02%) |
0/4852 (0.00%) |
Femoral hernia, obstructive |
0/4814 (0.00%) |
1/4852 (0.02%) |
Gastric haemorrhage |
2/4814 (0.04%) |
0/4852 (0.00%) |
Gastric ulcer |
2/4814 (0.04%) |
4/4852 (0.08%) |
Gastric ulcer haemorrhage |
0/4814 (0.00%) |
1/4852 (0.02%) |
Gastric ulcer perforation |
0/4814 (0.00%) |
1/4852 (0.02%) |
Gastritis |
2/4814 (0.04%) |
6/4852 (0.12%) |
Gastritis erosive |
0/4814 (0.00%) |
1/4852 (0.02%) |
Gastrointestinal disorder |
4/4814 (0.08%) |
1/4852 (0.02%) |
Gastrointestinal haemorrhage |
4/4814 (0.08%) |
6/4852 (0.12%) |
Gastrointestinal pain |
0/4814 (0.00%) |
1/4852 (0.02%) |
Gastrointestinal tract irritation |
0/4814 (0.00%) |
1/4852 (0.02%) |
Gastrooesophageal reflux disease |
2/4814 (0.04%) |
2/4852 (0.04%) |
Haematemesis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Haematochezia |
0/4814 (0.00%) |
1/4852 (0.02%) |
Haemorrhoids |
0/4814 (0.00%) |
2/4852 (0.04%) |
Hiatus hernia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Ileus |
2/4814 (0.04%) |
2/4852 (0.04%) |
Inguinal hernia |
0/4814 (0.00%) |
1/4852 (0.02%) |
Intestinal ischaemia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Intestinal obstruction |
5/4814 (0.10%) |
4/4852 (0.08%) |
Intestinal perforation |
1/4814 (0.02%) |
0/4852 (0.00%) |
Intestinal polyp |
0/4814 (0.00%) |
1/4852 (0.02%) |
Large intestine perforation |
2/4814 (0.04%) |
0/4852 (0.00%) |
Melaena |
0/4814 (0.00%) |
1/4852 (0.02%) |
Mesenteric occlusion |
0/4814 (0.00%) |
1/4852 (0.02%) |
Nausea |
3/4814 (0.06%) |
5/4852 (0.10%) |
Obstruction gastric |
0/4814 (0.00%) |
2/4852 (0.04%) |
Oesophageal disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Oesophageal haemorrhage |
1/4814 (0.02%) |
0/4852 (0.00%) |
Oesophageal stenosis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Oesophagitis |
1/4814 (0.02%) |
1/4852 (0.02%) |
Pancreatitis |
7/4814 (0.15%) |
5/4852 (0.10%) |
Pancreatitis acute |
1/4814 (0.02%) |
2/4852 (0.04%) |
Peptic ulcer |
1/4814 (0.02%) |
0/4852 (0.00%) |
Peritonitis |
1/4814 (0.02%) |
2/4852 (0.04%) |
Proctalgia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Rectal haemorrhage |
0/4814 (0.00%) |
1/4852 (0.02%) |
Reflux oesophagitis |
1/4814 (0.02%) |
1/4852 (0.02%) |
Small intestinal obstruction |
0/4814 (0.00%) |
1/4852 (0.02%) |
Splenic artery aneurysm |
1/4814 (0.02%) |
0/4852 (0.00%) |
Stomatitis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Tongue oedema |
1/4814 (0.02%) |
0/4852 (0.00%) |
Tongue ulceration |
0/4814 (0.00%) |
1/4852 (0.02%) |
Vomiting |
9/4814 (0.19%) |
6/4852 (0.12%) |
General disorders |
|
|
Adverse drug reaction |
0/4814 (0.00%) |
1/4852 (0.02%) |
Asthenia |
3/4814 (0.06%) |
6/4852 (0.12%) |
Calcinosis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Cardiac death |
0/4814 (0.00%) |
1/4852 (0.02%) |
Chest discomfort |
0/4814 (0.00%) |
1/4852 (0.02%) |
Chest pain |
15/4814 (0.31%) |
16/4852 (0.33%) |
Condition aggravated |
1/4814 (0.02%) |
0/4852 (0.00%) |
Cyst |
1/4814 (0.02%) |
0/4852 (0.00%) |
Death |
1/4814 (0.02%) |
1/4852 (0.02%) |
Device breakage |
0/4814 (0.00%) |
2/4852 (0.04%) |
Device occlusion |
0/4814 (0.00%) |
1/4852 (0.02%) |
Disease progression |
0/4814 (0.00%) |
4/4852 (0.08%) |
Dysplasia |
0/4814 (0.00%) |
1/4852 (0.02%) |
Fat necrosis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Fat tissue increased |
1/4814 (0.02%) |
0/4852 (0.00%) |
Fatigue |
4/4814 (0.08%) |
4/4852 (0.08%) |
Gait disturbance |
4/4814 (0.08%) |
1/4852 (0.02%) |
General physical health deterioration |
2/4814 (0.04%) |
2/4852 (0.04%) |
Hernia |
3/4814 (0.06%) |
5/4852 (0.10%) |
Hyperplasia |
3/4814 (0.06%) |
1/4852 (0.02%) |
Ill-defined disorder |
4/4814 (0.08%) |
8/4852 (0.16%) |
Impaired healing |
3/4814 (0.06%) |
0/4852 (0.00%) |
Implant site fibrosis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Local swelling |
1/4814 (0.02%) |
0/4852 (0.00%) |
Malaise |
3/4814 (0.06%) |
1/4852 (0.02%) |
Medical device complication |
1/4814 (0.02%) |
0/4852 (0.00%) |
Multi-organ failure |
1/4814 (0.02%) |
0/4852 (0.00%) |
Necrosis |
1/4814 (0.02%) |
2/4852 (0.04%) |
Nodule |
0/4814 (0.00%) |
1/4852 (0.02%) |
Oedema |
1/4814 (0.02%) |
1/4852 (0.02%) |
Oedema due to cardiac disease |
1/4814 (0.02%) |
0/4852 (0.00%) |
Oedema peripheral |
1/4814 (0.02%) |
1/4852 (0.02%) |
Pain |
13/4814 (0.27%) |
3/4852 (0.06%) |
Polyp |
4/4814 (0.08%) |
1/4852 (0.02%) |
Pseudocyst |
1/4814 (0.02%) |
0/4852 (0.00%) |
Pyrexia |
7/4814 (0.15%) |
5/4852 (0.10%) |
Sense of oppression |
0/4814 (0.00%) |
1/4852 (0.02%) |
Sudden death |
1/4814 (0.02%) |
1/4852 (0.02%) |
Swelling |
0/4814 (0.00%) |
1/4852 (0.02%) |
Hepatobiliary disorders |
|
|
Bile duct stone |
0/4814 (0.00%) |
2/4852 (0.04%) |
Biliary colic |
0/4814 (0.00%) |
2/4852 (0.04%) |
Cholecystitis |
13/4814 (0.27%) |
11/4852 (0.23%) |
Cholecystitis acute |
2/4814 (0.04%) |
0/4852 (0.00%) |
Cholecystitis chronic |
1/4814 (0.02%) |
0/4852 (0.00%) |
Cholelithiasis |
10/4814 (0.21%) |
14/4852 (0.29%) |
Gallbladder perforation |
1/4814 (0.02%) |
0/4852 (0.00%) |
Hepatic cirrhosis |
2/4814 (0.04%) |
0/4852 (0.00%) |
Hepatic cyst |
0/4814 (0.00%) |
1/4852 (0.02%) |
Hepatic function abnormal |
1/4814 (0.02%) |
1/4852 (0.02%) |
Hepatitis |
0/4814 (0.00%) |
2/4852 (0.04%) |
Liver disorder |
1/4814 (0.02%) |
1/4852 (0.02%) |
Immune system disorders |
|
|
Anaphylactic reaction |
1/4814 (0.02%) |
0/4852 (0.00%) |
Hypersensitivity |
1/4814 (0.02%) |
4/4852 (0.08%) |
Sarcoidosis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Infections and infestations |
|
|
Abscess |
3/4814 (0.06%) |
1/4852 (0.02%) |
Abscess limb |
0/4814 (0.00%) |
1/4852 (0.02%) |
Appendicitis |
4/4814 (0.08%) |
7/4852 (0.14%) |
Appendicitis perforated |
0/4814 (0.00%) |
2/4852 (0.04%) |
Arthritis bacterial |
2/4814 (0.04%) |
2/4852 (0.04%) |
Bacterial infection |
1/4814 (0.02%) |
5/4852 (0.10%) |
Breast abscess |
4/4814 (0.08%) |
2/4852 (0.04%) |
Breast cellulitis |
3/4814 (0.06%) |
2/4852 (0.04%) |
Breast infection |
1/4814 (0.02%) |
0/4852 (0.00%) |
Bronchitis |
6/4814 (0.12%) |
2/4852 (0.04%) |
Bronchopneumonia |
0/4814 (0.00%) |
1/4852 (0.02%) |
Cellulitis |
11/4814 (0.23%) |
7/4852 (0.14%) |
Cystitis |
1/4814 (0.02%) |
1/4852 (0.02%) |
Device related infection |
1/4814 (0.02%) |
2/4852 (0.04%) |
Diverticulitis |
7/4814 (0.15%) |
10/4852 (0.21%) |
Endocarditis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Endometritis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Erysipelas |
9/4814 (0.19%) |
7/4852 (0.14%) |
Escherichia urinary tract infection |
0/4814 (0.00%) |
1/4852 (0.02%) |
Gangrene |
1/4814 (0.02%) |
0/4852 (0.00%) |
Gastroenteritis |
6/4814 (0.12%) |
4/4852 (0.08%) |
Gastroenteritis salmonella |
1/4814 (0.02%) |
0/4852 (0.00%) |
Groin abscess |
1/4814 (0.02%) |
0/4852 (0.00%) |
Hepatitis C |
1/4814 (0.02%) |
0/4852 (0.00%) |
Herpes zoster |
1/4814 (0.02%) |
2/4852 (0.04%) |
Infection |
5/4814 (0.10%) |
11/4852 (0.23%) |
Lobar pneumonia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Localised infection |
0/4814 (0.00%) |
1/4852 (0.02%) |
Lower respiratory tract infection |
2/4814 (0.04%) |
0/4852 (0.00%) |
Lower respiratory tract infection bacterial |
1/4814 (0.02%) |
0/4852 (0.00%) |
Lung infection |
1/4814 (0.02%) |
1/4852 (0.02%) |
Lymphangitis |
2/4814 (0.04%) |
0/4852 (0.00%) |
Mastitis |
6/4814 (0.12%) |
5/4852 (0.10%) |
Meningitis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Molluscum contagiosum |
0/4814 (0.00%) |
1/4852 (0.02%) |
Nasopharyngitis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Osteomyelitis |
1/4814 (0.02%) |
1/4852 (0.02%) |
Pelvic inflammatory disease |
1/4814 (0.02%) |
0/4852 (0.00%) |
Pneumonia |
26/4814 (0.54%) |
25/4852 (0.52%) |
Pneumonia primary atypical |
1/4814 (0.02%) |
0/4852 (0.00%) |
Post procedural cellulitis |
2/4814 (0.04%) |
0/4852 (0.00%) |
Post procedural infection |
0/4814 (0.00%) |
1/4852 (0.02%) |
Pseudomembranous colitis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Pyelonephritis |
2/4814 (0.04%) |
1/4852 (0.02%) |
Pyelonephritis acute |
0/4814 (0.00%) |
1/4852 (0.02%) |
Pyoderma |
2/4814 (0.04%) |
0/4852 (0.00%) |
Sepsis |
10/4814 (0.21%) |
4/4852 (0.08%) |
Streptococcal sepsis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Subcutaneous abscess |
0/4814 (0.00%) |
1/4852 (0.02%) |
Upper respiratory tract infection |
0/4814 (0.00%) |
1/4852 (0.02%) |
Urinary tract infection |
6/4814 (0.12%) |
7/4852 (0.14%) |
Urosepsis |
1/4814 (0.02%) |
1/4852 (0.02%) |
Vestibular neuronitis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Viral infection |
0/4814 (0.00%) |
1/4852 (0.02%) |
Wound infection |
5/4814 (0.10%) |
0/4852 (0.00%) |
Injury, poisoning and procedural complications |
|
|
Acetabulum fracture |
1/4814 (0.02%) |
0/4852 (0.00%) |
Animal bite |
0/4814 (0.00%) |
1/4852 (0.02%) |
Ankle fracture |
6/4814 (0.12%) |
8/4852 (0.16%) |
Breast injury |
0/4814 (0.00%) |
1/4852 (0.02%) |
Cervical vertebral fracture |
0/4814 (0.00%) |
1/4852 (0.02%) |
Clavicle fracture |
1/4814 (0.02%) |
1/4852 (0.02%) |
Compression fracture |
0/4814 (0.00%) |
1/4852 (0.02%) |
Concussion |
1/4814 (0.02%) |
2/4852 (0.04%) |
Contusion |
1/4814 (0.02%) |
1/4852 (0.02%) |
Deep vein thrombosis postoperative |
1/4814 (0.02%) |
0/4852 (0.00%) |
Delayed recovery from anaesthesia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Fall |
7/4814 (0.15%) |
9/4852 (0.19%) |
Femoral neck fracture |
2/4814 (0.04%) |
3/4852 (0.06%) |
Femur fracture |
3/4814 (0.06%) |
4/4852 (0.08%) |
Fibula fracture |
1/4814 (0.02%) |
1/4852 (0.02%) |
Foot fracture |
2/4814 (0.04%) |
0/4852 (0.00%) |
Forearm fracture |
1/4814 (0.02%) |
0/4852 (0.00%) |
Fracture |
15/4814 (0.31%) |
27/4852 (0.56%) |
Fractured sacrum |
0/4814 (0.00%) |
1/4852 (0.02%) |
Hand fracture |
1/4814 (0.02%) |
1/4852 (0.02%) |
Head injury |
1/4814 (0.02%) |
0/4852 (0.00%) |
Hip fracture |
3/4814 (0.06%) |
8/4852 (0.16%) |
Humerus fracture |
2/4814 (0.04%) |
10/4852 (0.21%) |
Incisional hernia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Injury |
3/4814 (0.06%) |
0/4852 (0.00%) |
Joint dislocation |
2/4814 (0.04%) |
2/4852 (0.04%) |
Joint injury |
0/4814 (0.00%) |
1/4852 (0.02%) |
Joint sprain |
1/4814 (0.02%) |
0/4852 (0.00%) |
Laceration |
2/4814 (0.04%) |
1/4852 (0.02%) |
Lower limb fracture |
1/4814 (0.02%) |
0/4852 (0.00%) |
Lumbar vertebral fracture |
0/4814 (0.00%) |
2/4852 (0.04%) |
Meniscus lesion |
1/4814 (0.02%) |
2/4852 (0.04%) |
Overdose |
1/4814 (0.02%) |
1/4852 (0.02%) |
Patella fracture |
0/4814 (0.00%) |
2/4852 (0.04%) |
Pelvic fracture |
1/4814 (0.02%) |
5/4852 (0.10%) |
Poisoning |
1/4814 (0.02%) |
1/4852 (0.02%) |
Postoperative thrombosis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Postoperative wound complication |
1/4814 (0.02%) |
0/4852 (0.00%) |
Procedural pain |
0/4814 (0.00%) |
1/4852 (0.02%) |
Pubis fracture |
0/4814 (0.00%) |
1/4852 (0.02%) |
Radiation fibrosis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Radiation pneumonitis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Radiation skin injury |
0/4814 (0.00%) |
1/4852 (0.02%) |
Radius fracture |
0/4814 (0.00%) |
4/4852 (0.08%) |
Rib fracture |
2/4814 (0.04%) |
3/4852 (0.06%) |
Road traffic accident |
1/4814 (0.02%) |
1/4852 (0.02%) |
Seroma |
0/4814 (0.00%) |
2/4852 (0.04%) |
Spinal column injury |
0/4814 (0.00%) |
1/4852 (0.02%) |
Spinal compression fracture |
1/4814 (0.02%) |
1/4852 (0.02%) |
Spinal fracture |
3/4814 (0.06%) |
3/4852 (0.06%) |
Subdural haematoma |
3/4814 (0.06%) |
2/4852 (0.04%) |
Tendon rupture |
0/4814 (0.00%) |
1/4852 (0.02%) |
Tibia fracture |
2/4814 (0.04%) |
2/4852 (0.04%) |
Toxicity to various agents |
0/4814 (0.00%) |
1/4852 (0.02%) |
Ulna fracture |
0/4814 (0.00%) |
1/4852 (0.02%) |
Upper limb fracture |
1/4814 (0.02%) |
4/4852 (0.08%) |
Vascular bypass dysfunction |
1/4814 (0.02%) |
0/4852 (0.00%) |
Wrist fracture |
5/4814 (0.10%) |
6/4852 (0.12%) |
Investigations |
|
|
Blood calcium increased |
0/4814 (0.00%) |
1/4852 (0.02%) |
Blood test abnormal |
0/4814 (0.00%) |
1/4852 (0.02%) |
CSF test abnormal |
1/4814 (0.02%) |
0/4852 (0.00%) |
Carbohydrate antigen 15-3 increased |
0/4814 (0.00%) |
1/4852 (0.02%) |
Clostridium test positive |
0/4814 (0.00%) |
1/4852 (0.02%) |
Coagulation test |
1/4814 (0.02%) |
0/4852 (0.00%) |
Electrocardiogram abnormal |
0/4814 (0.00%) |
1/4852 (0.02%) |
Gamma-glutamyltransferase increased |
0/4814 (0.00%) |
1/4852 (0.02%) |
Haemoglobin |
0/4814 (0.00%) |
1/4852 (0.02%) |
Heart rate irregular |
0/4814 (0.00%) |
1/4852 (0.02%) |
Investigation |
0/4814 (0.00%) |
1/4852 (0.02%) |
Occult blood positive |
0/4814 (0.00%) |
1/4852 (0.02%) |
Prothrombin level increased |
1/4814 (0.02%) |
0/4852 (0.00%) |
Weight decreased |
1/4814 (0.02%) |
1/4852 (0.02%) |
Metabolism and nutrition disorders |
|
|
Cachexia |
0/4814 (0.00%) |
1/4852 (0.02%) |
Dehydration |
2/4814 (0.04%) |
9/4852 (0.19%) |
Diabetes mellitus |
4/4814 (0.08%) |
6/4852 (0.12%) |
Enzyme abnormality |
0/4814 (0.00%) |
1/4852 (0.02%) |
Hypercalcaemia |
1/4814 (0.02%) |
3/4852 (0.06%) |
Hypercholesterolaemia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Hyperglycaemia |
0/4814 (0.00%) |
1/4852 (0.02%) |
Hypoglycaemia |
2/4814 (0.04%) |
1/4852 (0.02%) |
Hypokalaemia |
1/4814 (0.02%) |
3/4852 (0.06%) |
Hypomagnesaemia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Hyponatraemia |
3/4814 (0.06%) |
5/4852 (0.10%) |
Type 1 diabetes mellitus |
0/4814 (0.00%) |
1/4852 (0.02%) |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
5/4814 (0.10%) |
8/4852 (0.16%) |
Arthritis |
11/4814 (0.23%) |
14/4852 (0.29%) |
Arthropathy |
3/4814 (0.06%) |
7/4852 (0.14%) |
Back pain |
6/4814 (0.12%) |
7/4852 (0.14%) |
Bone disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Bone pain |
2/4814 (0.04%) |
4/4852 (0.08%) |
Bursitis |
2/4814 (0.04%) |
1/4852 (0.02%) |
CREST syndrome |
0/4814 (0.00%) |
1/4852 (0.02%) |
Chondropathy |
0/4814 (0.00%) |
1/4852 (0.02%) |
Flank pain |
0/4814 (0.00%) |
1/4852 (0.02%) |
Foot deformity |
1/4814 (0.02%) |
1/4852 (0.02%) |
Groin pain |
1/4814 (0.02%) |
0/4852 (0.00%) |
Intervertebral disc protrusion |
3/4814 (0.06%) |
7/4852 (0.14%) |
Joint stiffness |
1/4814 (0.02%) |
0/4852 (0.00%) |
Joint swelling |
0/4814 (0.00%) |
1/4852 (0.02%) |
Lumbar spinal stenosis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Monarthritis |
1/4814 (0.02%) |
1/4852 (0.02%) |
Muscle spasms |
2/4814 (0.04%) |
1/4852 (0.02%) |
Muscular weakness |
1/4814 (0.02%) |
0/4852 (0.00%) |
Musculoskeletal chest pain |
1/4814 (0.02%) |
2/4852 (0.04%) |
Musculoskeletal disorder |
2/4814 (0.04%) |
0/4852 (0.00%) |
Musculoskeletal pain |
2/4814 (0.04%) |
1/4852 (0.02%) |
Myalgia |
0/4814 (0.00%) |
1/4852 (0.02%) |
Neck pain |
1/4814 (0.02%) |
5/4852 (0.10%) |
Osteoarthritis |
14/4814 (0.29%) |
34/4852 (0.70%) |
Osteolysis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Osteonecrosis |
2/4814 (0.04%) |
3/4852 (0.06%) |
Osteonecrosis of jaw |
1/4814 (0.02%) |
0/4852 (0.00%) |
Osteoporosis |
1/4814 (0.02%) |
3/4852 (0.06%) |
Osteoporosis postmenopausal |
1/4814 (0.02%) |
0/4852 (0.00%) |
Osteoporotic fracture |
1/4814 (0.02%) |
0/4852 (0.00%) |
Pain in extremity |
3/4814 (0.06%) |
0/4852 (0.00%) |
Pathological fracture |
2/4814 (0.04%) |
1/4852 (0.02%) |
Polyarthritis |
1/4814 (0.02%) |
1/4852 (0.02%) |
Rotator cuff syndrome |
3/4814 (0.06%) |
0/4852 (0.00%) |
Spinal column stenosis |
0/4814 (0.00%) |
3/4852 (0.06%) |
Spinal osteoarthritis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Synovial cyst |
1/4814 (0.02%) |
1/4852 (0.02%) |
Synovitis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Systemic sclerosis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Tendonitis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Acoustic neuroma |
0/4814 (0.00%) |
1/4852 (0.02%) |
Adenocarcinoma |
0/4814 (0.00%) |
1/4852 (0.02%) |
Adenoma benign |
2/4814 (0.04%) |
1/4852 (0.02%) |
Basal cell carcinoma |
1/4814 (0.02%) |
4/4852 (0.08%) |
Benign breast neoplasm |
4/4814 (0.08%) |
2/4852 (0.04%) |
Benign lymph node neoplasm |
1/4814 (0.02%) |
0/4852 (0.00%) |
Benign neoplasm of skin |
1/4814 (0.02%) |
0/4852 (0.00%) |
Benign ovarian tumour |
1/4814 (0.02%) |
0/4852 (0.00%) |
Benign renal neoplasm |
0/4814 (0.00%) |
1/4852 (0.02%) |
Benign respiratory tract neoplasm |
0/4814 (0.00%) |
1/4852 (0.02%) |
Bile duct cancer |
1/4814 (0.02%) |
0/4852 (0.00%) |
Bladder cancer recurrent |
0/4814 (0.00%) |
1/4852 (0.02%) |
Bowen's disease |
1/4814 (0.02%) |
0/4852 (0.00%) |
Breast cancer |
2/4814 (0.04%) |
3/4852 (0.06%) |
Breast cancer metastatic |
2/4814 (0.04%) |
1/4852 (0.02%) |
Breast cancer recurrent |
0/4814 (0.00%) |
4/4852 (0.08%) |
Cholesteatoma |
1/4814 (0.02%) |
0/4852 (0.00%) |
Colon cancer |
0/4814 (0.00%) |
1/4852 (0.02%) |
Colorectal cancer |
0/4814 (0.00%) |
1/4852 (0.02%) |
Contralateral breast cancer |
2/4814 (0.04%) |
2/4852 (0.04%) |
Dermatofibrosarcoma |
1/4814 (0.02%) |
0/4852 (0.00%) |
Endometrial cancer |
2/4814 (0.04%) |
3/4852 (0.06%) |
Fibroadenoma of breast |
1/4814 (0.02%) |
0/4852 (0.00%) |
Gastrointestinal neoplasm |
0/4814 (0.00%) |
1/4852 (0.02%) |
Haemangioma |
0/4814 (0.00%) |
1/4852 (0.02%) |
Hepatic neoplasm |
1/4814 (0.02%) |
0/4852 (0.00%) |
Hepatic neoplasm malignant |
1/4814 (0.02%) |
0/4852 (0.00%) |
Laryngeal cancer |
1/4814 (0.02%) |
0/4852 (0.00%) |
Lipoma |
2/4814 (0.04%) |
1/4852 (0.02%) |
Lung neoplasm |
1/4814 (0.02%) |
0/4852 (0.00%) |
Lung neoplasm malignant |
0/4814 (0.00%) |
2/4852 (0.04%) |
Lymphoma |
1/4814 (0.02%) |
0/4852 (0.00%) |
Malignant melanoma |
1/4814 (0.02%) |
1/4852 (0.02%) |
Malignant peritoneal neoplasm |
1/4814 (0.02%) |
0/4852 (0.00%) |
Malignant pleural effusion |
1/4814 (0.02%) |
0/4852 (0.00%) |
Mantle cell lymphoma |
1/4814 (0.02%) |
0/4852 (0.00%) |
Meningioma |
1/4814 (0.02%) |
3/4852 (0.06%) |
Metastases to bone |
4/4814 (0.08%) |
8/4852 (0.16%) |
Metastases to central nervous system |
0/4814 (0.00%) |
1/4852 (0.02%) |
Metastases to liver |
2/4814 (0.04%) |
2/4852 (0.04%) |
Metastases to lung |
1/4814 (0.02%) |
2/4852 (0.04%) |
Metastases to pancreas |
0/4814 (0.00%) |
1/4852 (0.02%) |
Metastases to pleura |
1/4814 (0.02%) |
0/4852 (0.00%) |
Metastases to skin |
0/4814 (0.00%) |
1/4852 (0.02%) |
Metastases to spine |
1/4814 (0.02%) |
2/4852 (0.04%) |
Metastases to stomach |
0/4814 (0.00%) |
1/4852 (0.02%) |
Metastasis |
2/4814 (0.04%) |
3/4852 (0.06%) |
Mueller's mixed tumour |
1/4814 (0.02%) |
0/4852 (0.00%) |
Myelodysplastic syndrome |
1/4814 (0.02%) |
1/4852 (0.02%) |
Neoplasm |
1/4814 (0.02%) |
0/4852 (0.00%) |
Neoplasm malignant |
2/4814 (0.04%) |
2/4852 (0.04%) |
Neoplasm recurrence |
0/4814 (0.00%) |
1/4852 (0.02%) |
Neuroma |
1/4814 (0.02%) |
1/4852 (0.02%) |
Ovarian adenoma |
0/4814 (0.00%) |
3/4852 (0.06%) |
Ovarian cancer |
0/4814 (0.00%) |
2/4852 (0.04%) |
Ovarian germ cell teratoma benign |
0/4814 (0.00%) |
1/4852 (0.02%) |
Ovarian neoplasm |
1/4814 (0.02%) |
3/4852 (0.06%) |
Paget's disease of the breast |
1/4814 (0.02%) |
0/4852 (0.00%) |
Pancreatic carcinoma |
1/4814 (0.02%) |
0/4852 (0.00%) |
Pharyngeal neoplasm |
0/4814 (0.00%) |
1/4852 (0.02%) |
Rectal cancer |
0/4814 (0.00%) |
2/4852 (0.04%) |
Thyroid adenoma |
0/4814 (0.00%) |
2/4852 (0.04%) |
Thyroid cancer |
1/4814 (0.02%) |
0/4852 (0.00%) |
Thyroid neoplasm |
1/4814 (0.02%) |
2/4852 (0.04%) |
Ureteric cancer |
1/4814 (0.02%) |
0/4852 (0.00%) |
Uterine cancer |
1/4814 (0.02%) |
0/4852 (0.00%) |
Uterine leiomyoma |
2/4814 (0.04%) |
4/4852 (0.08%) |
Vulval cancer |
0/4814 (0.00%) |
1/4852 (0.02%) |
Nervous system disorders |
|
|
Alcoholic seizure |
0/4814 (0.00%) |
1/4852 (0.02%) |
Aphasia |
2/4814 (0.04%) |
2/4852 (0.04%) |
Apraxia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Ataxia |
1/4814 (0.02%) |
1/4852 (0.02%) |
Carotid artery stenosis |
0/4814 (0.00%) |
3/4852 (0.06%) |
Carotid artery thrombosis |
2/4814 (0.04%) |
1/4852 (0.02%) |
Carpal tunnel syndrome |
2/4814 (0.04%) |
3/4852 (0.06%) |
Cerebellar infarction |
0/4814 (0.00%) |
2/4852 (0.04%) |
Cerebral artery thrombosis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Cerebral haemorrhage |
3/4814 (0.06%) |
3/4852 (0.06%) |
Cerebral infarction |
3/4814 (0.06%) |
6/4852 (0.12%) |
Cerebral ischaemia |
2/4814 (0.04%) |
5/4852 (0.10%) |
Cerebrovascular accident |
20/4814 (0.42%) |
26/4852 (0.54%) |
Cerebrovascular disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Cervicobrachial syndrome |
0/4814 (0.00%) |
2/4852 (0.04%) |
Coma |
1/4814 (0.02%) |
3/4852 (0.06%) |
Coma hepatic |
0/4814 (0.00%) |
1/4852 (0.02%) |
Convulsion |
1/4814 (0.02%) |
2/4852 (0.04%) |
Dementia |
0/4814 (0.00%) |
2/4852 (0.04%) |
Dementia Alzheimer's type |
1/4814 (0.02%) |
0/4852 (0.00%) |
Depressed level of consciousness |
0/4814 (0.00%) |
2/4852 (0.04%) |
Dizziness |
5/4814 (0.10%) |
4/4852 (0.08%) |
Drop attacks |
1/4814 (0.02%) |
0/4852 (0.00%) |
Dyskinesia |
0/4814 (0.00%) |
2/4852 (0.04%) |
Encephalopathy |
0/4814 (0.00%) |
1/4852 (0.02%) |
Epilepsy |
1/4814 (0.02%) |
3/4852 (0.06%) |
Extrapyramidal disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Facial paresis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Grand mal convulsion |
0/4814 (0.00%) |
1/4852 (0.02%) |
Headache |
5/4814 (0.10%) |
5/4852 (0.10%) |
Hemiparesis |
1/4814 (0.02%) |
1/4852 (0.02%) |
Hypoaesthesia |
0/4814 (0.00%) |
1/4852 (0.02%) |
IIIrd nerve paresis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Ischaemic stroke |
1/4814 (0.02%) |
2/4852 (0.04%) |
Loss of consciousness |
1/4814 (0.02%) |
3/4852 (0.06%) |
Mental impairment |
0/4814 (0.00%) |
1/4852 (0.02%) |
Migraine |
1/4814 (0.02%) |
1/4852 (0.02%) |
Myelitis transverse |
0/4814 (0.00%) |
1/4852 (0.02%) |
Myelopathy |
0/4814 (0.00%) |
1/4852 (0.02%) |
Nervous system disorder |
1/4814 (0.02%) |
1/4852 (0.02%) |
Neuralgia |
1/4814 (0.02%) |
3/4852 (0.06%) |
Neuritis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Neurological symptom |
1/4814 (0.02%) |
0/4852 (0.00%) |
Paraesthesia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Partial seizures |
1/4814 (0.02%) |
1/4852 (0.02%) |
Sciatica |
2/4814 (0.04%) |
2/4852 (0.04%) |
Sedation |
0/4814 (0.00%) |
1/4852 (0.02%) |
Sensory disturbance |
2/4814 (0.04%) |
0/4852 (0.00%) |
Somnolence |
1/4814 (0.02%) |
0/4852 (0.00%) |
Spinal cord compression |
0/4814 (0.00%) |
1/4852 (0.02%) |
Subarachnoid haemorrhage |
0/4814 (0.00%) |
2/4852 (0.04%) |
Syncope |
12/4814 (0.25%) |
13/4852 (0.27%) |
Thalamic infarction |
0/4814 (0.00%) |
1/4852 (0.02%) |
Transient ischaemic attack |
11/4814 (0.23%) |
11/4852 (0.23%) |
Psychiatric disorders |
|
|
Alcohol abuse |
0/4814 (0.00%) |
1/4852 (0.02%) |
Anxiety |
1/4814 (0.02%) |
2/4852 (0.04%) |
Bipolar I disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Completed suicide |
1/4814 (0.02%) |
0/4852 (0.00%) |
Confusional state |
2/4814 (0.04%) |
4/4852 (0.08%) |
Delirium |
1/4814 (0.02%) |
1/4852 (0.02%) |
Depression |
10/4814 (0.21%) |
9/4852 (0.19%) |
Depression suicidal |
2/4814 (0.04%) |
0/4852 (0.00%) |
Emotional distress |
1/4814 (0.02%) |
1/4852 (0.02%) |
Major depression |
0/4814 (0.00%) |
1/4852 (0.02%) |
Mental disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Mood altered |
2/4814 (0.04%) |
0/4852 (0.00%) |
Suicidal ideation |
0/4814 (0.00%) |
1/4852 (0.02%) |
Suicide attempt |
1/4814 (0.02%) |
0/4852 (0.00%) |
Renal and urinary disorders |
|
|
Bladder prolapse |
1/4814 (0.02%) |
2/4852 (0.04%) |
Calculus bladder |
1/4814 (0.02%) |
0/4852 (0.00%) |
Dysuria |
0/4814 (0.00%) |
2/4852 (0.04%) |
Haematuria |
1/4814 (0.02%) |
1/4852 (0.02%) |
Haemorrhage urinary tract |
1/4814 (0.02%) |
0/4852 (0.00%) |
Hydronephrosis |
1/4814 (0.02%) |
1/4852 (0.02%) |
Incontinence |
1/4814 (0.02%) |
0/4852 (0.00%) |
Nephrolithiasis |
2/4814 (0.04%) |
2/4852 (0.04%) |
Renal artery stenosis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Renal colic |
1/4814 (0.02%) |
0/4852 (0.00%) |
Renal disorder |
1/4814 (0.02%) |
1/4852 (0.02%) |
Renal failure |
4/4814 (0.08%) |
7/4852 (0.14%) |
Renal failure acute |
1/4814 (0.02%) |
3/4852 (0.06%) |
Renal infarct |
1/4814 (0.02%) |
0/4852 (0.00%) |
Stress urinary incontinence |
1/4814 (0.02%) |
0/4852 (0.00%) |
Ureteric obstruction |
0/4814 (0.00%) |
1/4852 (0.02%) |
Urinary bladder polyp |
1/4814 (0.02%) |
0/4852 (0.00%) |
Urinary incontinence |
1/4814 (0.02%) |
4/4852 (0.08%) |
Urinary retention |
1/4814 (0.02%) |
1/4852 (0.02%) |
Urogenital disorder |
2/4814 (0.04%) |
0/4852 (0.00%) |
Reproductive system and breast disorders |
|
|
Breast calcifications |
4/4814 (0.08%) |
4/4852 (0.08%) |
Breast cyst |
2/4814 (0.04%) |
0/4852 (0.00%) |
Breast disorder |
1/4814 (0.02%) |
7/4852 (0.14%) |
Breast enlargement |
1/4814 (0.02%) |
2/4852 (0.04%) |
Breast fibrosis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Breast haematoma |
1/4814 (0.02%) |
1/4852 (0.02%) |
Breast hyperplasia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Breast mass |
3/4814 (0.06%) |
4/4852 (0.08%) |
Breast necrosis |
0/4814 (0.00%) |
4/4852 (0.08%) |
Cervical dysplasia |
1/4814 (0.02%) |
2/4852 (0.04%) |
Cervical polyp |
4/4814 (0.08%) |
0/4852 (0.00%) |
Cystocele |
2/4814 (0.04%) |
0/4852 (0.00%) |
Endometrial atrophy |
2/4814 (0.04%) |
0/4852 (0.00%) |
Endometrial disorder |
2/4814 (0.04%) |
1/4852 (0.02%) |
Endometrial hyperplasia |
17/4814 (0.35%) |
0/4852 (0.00%) |
Endometrial hypertrophy |
3/4814 (0.06%) |
0/4852 (0.00%) |
Female genital tract fistula |
0/4814 (0.00%) |
1/4852 (0.02%) |
Fibrocystic breast disease |
0/4814 (0.00%) |
1/4852 (0.02%) |
Genital prolapse |
3/4814 (0.06%) |
0/4852 (0.00%) |
Menorrhagia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Menstruation irregular |
1/4814 (0.02%) |
0/4852 (0.00%) |
Metrorrhagia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Nipple disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Ovarian cyst |
6/4814 (0.12%) |
4/4852 (0.08%) |
Ovarian disorder |
1/4814 (0.02%) |
1/4852 (0.02%) |
Pelvic pain |
3/4814 (0.06%) |
1/4852 (0.02%) |
Postmenopausal haemorrhage |
3/4814 (0.06%) |
1/4852 (0.02%) |
Rectocele |
3/4814 (0.06%) |
1/4852 (0.02%) |
Urogenital prolapse |
1/4814 (0.02%) |
0/4852 (0.00%) |
Uterine atony |
1/4814 (0.02%) |
0/4852 (0.00%) |
Uterine disorder |
2/4814 (0.04%) |
0/4852 (0.00%) |
Uterine haemorrhage |
0/4814 (0.00%) |
1/4852 (0.02%) |
Uterine polyp |
12/4814 (0.25%) |
1/4852 (0.02%) |
Uterine prolapse |
5/4814 (0.10%) |
1/4852 (0.02%) |
Vaginal disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Vaginal haemorrhage |
9/4814 (0.19%) |
4/4852 (0.08%) |
Vaginal polyp |
1/4814 (0.02%) |
0/4852 (0.00%) |
Vaginal prolapse |
3/4814 (0.06%) |
1/4852 (0.02%) |
Vulval disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Vulval oedema |
0/4814 (0.00%) |
1/4852 (0.02%) |
Vulvovaginal disorder |
1/4814 (0.02%) |
1/4852 (0.02%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Acute pulmonary oedema |
0/4814 (0.00%) |
2/4852 (0.04%) |
Acute respiratory failure |
0/4814 (0.00%) |
1/4852 (0.02%) |
Apnoea |
0/4814 (0.00%) |
1/4852 (0.02%) |
Aspiration |
1/4814 (0.02%) |
0/4852 (0.00%) |
Asthma |
2/4814 (0.04%) |
0/4852 (0.00%) |
Atelectasis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Bronchial obstruction |
0/4814 (0.00%) |
1/4852 (0.02%) |
Bronchitis chronic |
1/4814 (0.02%) |
0/4852 (0.00%) |
Chronic obstructive pulmonary disease |
4/4814 (0.08%) |
2/4852 (0.04%) |
Cough |
2/4814 (0.04%) |
1/4852 (0.02%) |
Diaphragmatic disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Dyspnoea |
13/4814 (0.27%) |
28/4852 (0.58%) |
Dyspnoea exertional |
1/4814 (0.02%) |
3/4852 (0.06%) |
Emphysema |
1/4814 (0.02%) |
0/4852 (0.00%) |
Eosinophilic pneumonia |
0/4814 (0.00%) |
1/4852 (0.02%) |
Epistaxis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Haemoptysis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Hypoxia |
2/4814 (0.04%) |
1/4852 (0.02%) |
Lung disorder |
5/4814 (0.10%) |
7/4852 (0.14%) |
Lung infiltration |
0/4814 (0.00%) |
1/4852 (0.02%) |
Nasal septum deviation |
0/4814 (0.00%) |
1/4852 (0.02%) |
Nasal turbinate hypertrophy |
0/4814 (0.00%) |
1/4852 (0.02%) |
Obstructive airways disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Paranasal cyst |
0/4814 (0.00%) |
1/4852 (0.02%) |
Pleural effusion |
2/4814 (0.04%) |
7/4852 (0.14%) |
Pleurisy |
1/4814 (0.02%) |
2/4852 (0.04%) |
Pleuritic pain |
1/4814 (0.02%) |
0/4852 (0.00%) |
Pneumonitis |
0/4814 (0.00%) |
4/4852 (0.08%) |
Pneumothorax |
3/4814 (0.06%) |
2/4852 (0.04%) |
Productive cough |
1/4814 (0.02%) |
0/4852 (0.00%) |
Pulmonary congestion |
0/4814 (0.00%) |
1/4852 (0.02%) |
Pulmonary embolism |
22/4814 (0.46%) |
24/4852 (0.49%) |
Pulmonary hypertension |
0/4814 (0.00%) |
1/4852 (0.02%) |
Pulmonary mass |
0/4814 (0.00%) |
1/4852 (0.02%) |
Pulmonary oedema |
2/4814 (0.04%) |
2/4852 (0.04%) |
Respiratory disorder |
1/4814 (0.02%) |
1/4852 (0.02%) |
Respiratory distress |
1/4814 (0.02%) |
0/4852 (0.00%) |
Respiratory failure |
1/4814 (0.02%) |
4/4852 (0.08%) |
Sinus disorder |
1/4814 (0.02%) |
0/4852 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
Acute febrile neutrophilic dermatosis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Dermatitis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Dermatitis allergic |
1/4814 (0.02%) |
0/4852 (0.00%) |
Eczema |
1/4814 (0.02%) |
0/4852 (0.00%) |
Nail disorder |
1/4814 (0.02%) |
0/4852 (0.00%) |
Panniculitis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Pruritus |
0/4814 (0.00%) |
1/4852 (0.02%) |
Rash |
3/4814 (0.06%) |
3/4852 (0.06%) |
Scar |
1/4814 (0.02%) |
3/4852 (0.06%) |
Skin disorder |
2/4814 (0.04%) |
0/4852 (0.00%) |
Skin lesion |
1/4814 (0.02%) |
0/4852 (0.00%) |
Skin necrosis |
1/4814 (0.02%) |
1/4852 (0.02%) |
Skin ulcer |
1/4814 (0.02%) |
2/4852 (0.04%) |
Urticaria |
1/4814 (0.02%) |
1/4852 (0.02%) |
Surgical and medical procedures |
|
|
Alcohol detoxification |
0/4814 (0.00%) |
1/4852 (0.02%) |
Angioplasty |
1/4814 (0.02%) |
0/4852 (0.00%) |
Aortic valve replacement |
0/4814 (0.00%) |
1/4852 (0.02%) |
Arterial bypass operation |
1/4814 (0.02%) |
0/4852 (0.00%) |
Bile duct stent insertion |
1/4814 (0.02%) |
0/4852 (0.00%) |
Breast lump removal |
1/4814 (0.02%) |
1/4852 (0.02%) |
Breast operation |
2/4814 (0.04%) |
2/4852 (0.04%) |
Breast reconstruction |
3/4814 (0.06%) |
2/4852 (0.04%) |
Bunion operation |
0/4814 (0.00%) |
1/4852 (0.02%) |
Cardiac pacemaker insertion |
1/4814 (0.02%) |
0/4852 (0.00%) |
Cardiac pacemaker replacement |
0/4814 (0.00%) |
1/4852 (0.02%) |
Carpal tunnel decompression |
0/4814 (0.00%) |
1/4852 (0.02%) |
Cast application |
0/4814 (0.00%) |
1/4852 (0.02%) |
Cataract operation |
3/4814 (0.06%) |
2/4852 (0.04%) |
Cholecystectomy |
5/4814 (0.10%) |
4/4852 (0.08%) |
Cholelithotomy |
1/4814 (0.02%) |
0/4852 (0.00%) |
Colporrhaphy |
1/4814 (0.02%) |
0/4852 (0.00%) |
Coronary arterial stent insertion |
1/4814 (0.02%) |
0/4852 (0.00%) |
Coronary artery bypass |
1/4814 (0.02%) |
0/4852 (0.00%) |
Drug therapy |
1/4814 (0.02%) |
0/4852 (0.00%) |
Eventration procedure |
1/4814 (0.02%) |
0/4852 (0.00%) |
Female genital operation |
1/4814 (0.02%) |
2/4852 (0.04%) |
Gastric bypass |
1/4814 (0.02%) |
0/4852 (0.00%) |
Gastric operation |
1/4814 (0.02%) |
0/4852 (0.00%) |
Haemangioma removal |
1/4814 (0.02%) |
0/4852 (0.00%) |
Hernia repair |
0/4814 (0.00%) |
3/4852 (0.06%) |
Hip arthroplasty |
4/4814 (0.08%) |
10/4852 (0.21%) |
Hip surgery |
0/4814 (0.00%) |
1/4852 (0.02%) |
Hospitalisation |
0/4814 (0.00%) |
1/4852 (0.02%) |
Hysterectomy |
3/4814 (0.06%) |
1/4852 (0.02%) |
Inguinal hernia repair |
1/4814 (0.02%) |
0/4852 (0.00%) |
Intervertebral disc operation |
0/4814 (0.00%) |
1/4852 (0.02%) |
Joint arthroplasty |
0/4814 (0.00%) |
2/4852 (0.04%) |
Knee arthroplasty |
7/4814 (0.15%) |
4/4852 (0.08%) |
Knee operation |
2/4814 (0.04%) |
1/4852 (0.02%) |
Lipoma excision |
0/4814 (0.00%) |
1/4852 (0.02%) |
Mastectomy |
4/4814 (0.08%) |
1/4852 (0.02%) |
Medical device removal |
1/4814 (0.02%) |
0/4852 (0.00%) |
Meniscus operation |
1/4814 (0.02%) |
1/4852 (0.02%) |
Meniscus removal |
0/4814 (0.00%) |
1/4852 (0.02%) |
Oophorectomy |
1/4814 (0.02%) |
0/4852 (0.00%) |
Osteosynthesis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Phlebectomy |
0/4814 (0.00%) |
1/4852 (0.02%) |
Prolapse repair |
0/4814 (0.00%) |
1/4852 (0.02%) |
Radical hysterectomy |
1/4814 (0.02%) |
0/4852 (0.00%) |
Retinal operation |
1/4814 (0.02%) |
0/4852 (0.00%) |
Rotator cuff repair |
1/4814 (0.02%) |
0/4852 (0.00%) |
Scar excision |
1/4814 (0.02%) |
1/4852 (0.02%) |
Shoulder arthroplasty |
2/4814 (0.04%) |
0/4852 (0.00%) |
Simple mastectomy |
2/4814 (0.04%) |
0/4852 (0.00%) |
Skin neoplasm excision |
1/4814 (0.02%) |
1/4852 (0.02%) |
Spinal laminectomy |
0/4814 (0.00%) |
1/4852 (0.02%) |
Surgery |
0/4814 (0.00%) |
1/4852 (0.02%) |
Tendon operation |
0/4814 (0.00%) |
1/4852 (0.02%) |
Thyroid nodule removal |
1/4814 (0.02%) |
0/4852 (0.00%) |
Thyroidectomy |
0/4814 (0.00%) |
5/4852 (0.10%) |
Toe amputation |
1/4814 (0.02%) |
0/4852 (0.00%) |
Toe operation |
0/4814 (0.00%) |
1/4852 (0.02%) |
Uterine dilation and curettage |
1/4814 (0.02%) |
0/4852 (0.00%) |
Uterine prolapse repair |
1/4814 (0.02%) |
1/4852 (0.02%) |
Vaginal operation |
0/4814 (0.00%) |
1/4852 (0.02%) |
Varicose vein operation |
0/4814 (0.00%) |
2/4852 (0.04%) |
Vascular operation |
0/4814 (0.00%) |
1/4852 (0.02%) |
Vascular disorders |
|
|
Aneurysm |
0/4814 (0.00%) |
4/4852 (0.08%) |
Aortic aneurysm |
1/4814 (0.02%) |
1/4852 (0.02%) |
Aortic stenosis |
2/4814 (0.04%) |
5/4852 (0.10%) |
Arterial occlusive disease |
1/4814 (0.02%) |
0/4852 (0.00%) |
Arteriosclerosis |
1/4814 (0.02%) |
2/4852 (0.04%) |
Arteritis |
1/4814 (0.02%) |
1/4852 (0.02%) |
Circulatory collapse |
1/4814 (0.02%) |
3/4852 (0.06%) |
Deep vein thrombosis |
14/4814 (0.29%) |
6/4852 (0.12%) |
Embolism |
4/4814 (0.08%) |
2/4852 (0.04%) |
Femoral arterial stenosis |
0/4814 (0.00%) |
1/4852 (0.02%) |
Femoral artery occlusion |
0/4814 (0.00%) |
1/4852 (0.02%) |
Flushing |
2/4814 (0.04%) |
0/4852 (0.00%) |
Haematoma |
3/4814 (0.06%) |
0/4852 (0.00%) |
Haemorrhage |
2/4814 (0.04%) |
1/4852 (0.02%) |
Hot flush |
2/4814 (0.04%) |
0/4852 (0.00%) |
Hypertension |
6/4814 (0.12%) |
11/4852 (0.23%) |
Hypertensive crisis |
0/4814 (0.00%) |
8/4852 (0.16%) |
Hypotension |
0/4814 (0.00%) |
2/4852 (0.04%) |
Intermittent claudication |
1/4814 (0.02%) |
0/4852 (0.00%) |
Ischaemia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Lymphoedema |
0/4814 (0.00%) |
3/4852 (0.06%) |
Peripheral arterial occlusive disease |
1/4814 (0.02%) |
0/4852 (0.00%) |
Peripheral ischaemia |
1/4814 (0.02%) |
0/4852 (0.00%) |
Peripheral vascular disorder |
0/4814 (0.00%) |
1/4852 (0.02%) |
Phlebitis |
8/4814 (0.17%) |
2/4852 (0.04%) |
Shock |
1/4814 (0.02%) |
0/4852 (0.00%) |
Thrombophlebitis |
5/4814 (0.10%) |
0/4852 (0.00%) |
Thrombosis |
13/4814 (0.27%) |
6/4852 (0.12%) |
Varicophlebitis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Varicose vein |
1/4814 (0.02%) |
7/4852 (0.14%) |
Vasculitis |
1/4814 (0.02%) |
0/4852 (0.00%) |
Venoocclusive disease |
0/4814 (0.00%) |
1/4852 (0.02%) |
Venous thrombosis |
6/4814 (0.12%) |
2/4852 (0.04%) |
Indicates events were collected by non-systematic assessment
Term from vocabulary, MedDRA 14.0
|
|
Frequency Threshold for Reporting Other Adverse Events
|
2%
|
|
Tamoxifen Followed by Exemestane
|
Exemestane
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
3551/4814 (73.76%) |
3567/4852 (73.52%) |
Ear and labyrinth disorders |
|
|
Vertigo |
78/4814 (1.62%) |
96/4852 (1.98%) |
Gastrointestinal disorders |
|
|
Abdominal pain |
150/4814 (3.12%) |
141/4852 (2.91%) |
Constipation |
274/4814 (5.69%) |
236/4852 (4.86%) |
Diarrhoea |
258/4814 (5.36%) |
302/4852 (6.22%) |
Dry mouth |
98/4814 (2.04%) |
70/4852 (1.44%) |
Dyspepsia |
135/4814 (2.80%) |
151/4852 (3.11%) |
Nausea |
482/4814 (10.01%) |
419/4852 (8.64%) |
Vomiting |
106/4814 (2.20%) |
96/4852 (1.98%) |
General disorders |
|
|
Asthenia |
188/4814 (3.91%) |
235/4852 (4.84%) |
Chest pain |
91/4814 (1.89%) |
100/4852 (2.06%) |
Fatigue |
800/4814 (16.62%) |
796/4852 (16.41%) |
Oedema |
287/4814 (5.96%) |
276/4852 (5.69%) |
Oedema peripheral |
214/4814 (4.45%) |
166/4852 (3.42%) |
Pain |
492/4814 (10.22%) |
541/4852 (11.15%) |
Infections and infestations |
|
|
Bronchitis |
135/4814 (2.80%) |
128/4852 (2.64%) |
Cystitis |
76/4814 (1.58%) |
102/4852 (2.10%) |
Herpes zoster |
76/4814 (1.58%) |
112/4852 (2.31%) |
Infection |
197/4814 (4.09%) |
168/4852 (3.46%) |
Nasopharyngitis |
99/4814 (2.06%) |
110/4852 (2.27%) |
Urinary tract infection |
114/4814 (2.37%) |
129/4852 (2.66%) |
Vaginal infection |
100/4814 (2.08%) |
47/4852 (0.97%) |
Investigations |
|
|
Weight decreased |
140/4814 (2.91%) |
187/4852 (3.85%) |
Weight increased |
415/4814 (8.62%) |
339/4852 (6.99%) |
Metabolism and nutrition disorders |
|
|
Decreased appetite |
118/4814 (2.45%) |
132/4852 (2.72%) |
Hypercholesterolaemia |
99/4814 (2.06%) |
190/4852 (3.92%) |
Hyperglycaemia |
97/4814 (2.01%) |
113/4852 (2.33%) |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
1002/4814 (20.81%) |
1157/4852 (23.85%) |
Arthritis |
130/4814 (2.70%) |
161/4852 (3.32%) |
Back pain |
269/4814 (5.59%) |
273/4852 (5.63%) |
Bone pain |
230/4814 (4.78%) |
261/4852 (5.38%) |
Muscle spasms |
245/4814 (5.09%) |
133/4852 (2.74%) |
Musculoskeletal pain |
128/4814 (2.66%) |
176/4852 (3.63%) |
Myalgia |
360/4814 (7.48%) |
364/4852 (7.50%) |
Osteoarthritis |
142/4814 (2.95%) |
165/4852 (3.40%) |
Osteoporosis |
219/4814 (4.55%) |
428/4852 (8.82%) |
Pain in extremity |
147/4814 (3.05%) |
171/4852 (3.52%) |
Nervous system disorders |
|
|
Amnesia |
143/4814 (2.97%) |
188/4852 (3.87%) |
Carpal tunnel syndrome |
76/4814 (1.58%) |
109/4852 (2.25%) |
Dizziness |
289/4814 (6.00%) |
243/4852 (5.01%) |
Headache |
372/4814 (7.73%) |
369/4852 (7.61%) |
Neuropathy peripheral |
120/4814 (2.49%) |
174/4852 (3.59%) |
Paraesthesia |
66/4814 (1.37%) |
100/4852 (2.06%) |
Psychiatric disorders |
|
|
Anxiety |
174/4814 (3.61%) |
167/4852 (3.44%) |
Depression |
417/4814 (8.66%) |
404/4852 (8.33%) |
Insomnia |
452/4814 (9.39%) |
549/4852 (11.31%) |
Libido decreased |
164/4814 (3.41%) |
196/4852 (4.04%) |
Mood altered |
147/4814 (3.05%) |
151/4852 (3.11%) |
Sleep disorder |
61/4814 (1.27%) |
110/4852 (2.27%) |
Reproductive system and breast disorders |
|
|
Breast pain |
104/4814 (2.16%) |
121/4852 (2.49%) |
Vaginal discharge |
316/4814 (6.56%) |
111/4852 (2.29%) |
Vaginal haemorrhage |
186/4814 (3.86%) |
94/4852 (1.94%) |
Vulvovaginal dryness |
268/4814 (5.57%) |
321/4852 (6.62%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Cough |
252/4814 (5.23%) |
235/4852 (4.84%) |
Dyspnoea |
243/4814 (5.05%) |
223/4852 (4.60%) |
Skin and subcutaneous tissue disorders |
|
|
Alopecia |
299/4814 (6.21%) |
329/4852 (6.78%) |
Dry skin |
122/4814 (2.53%) |
114/4852 (2.35%) |
Hyperhidrosis |
175/4814 (3.64%) |
103/4852 (2.12%) |
Night sweats |
102/4814 (2.12%) |
87/4852 (1.79%) |
Pruritus |
158/4814 (3.28%) |
153/4852 (3.15%) |
Rash |
216/4814 (4.49%) |
227/4852 (4.68%) |
Vascular disorders |
|
|
Flushing |
183/4814 (3.80%) |
114/4852 (2.35%) |
Hot flush |
1690/4814 (35.11%) |
1517/4852 (31.27%) |
Hypertension |
224/4814 (4.65%) |
291/4852 (6.00%) |
Lymphoedema |
247/4814 (5.13%) |
227/4852 (4.68%) |
Indicates events were collected by non-systematic assessment
Term from vocabulary, MedDRA 14.0
|