Time Frame |
Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
Placebo
|
Linagliptin
|
Arm/Group Description |
Patients were administered Placebo ...
|
Patients were administered Linaglip...
|
Arm/Group Description |
Patients were administered Placebo matching Linagliptin 5 mg film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
Patients were administered Linagliptin 5 milligram (mg) film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
|
|
Placebo
|
Linagliptin
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
253/3485 (7.26%) |
250/3494 (7.16%) |
|
|
Placebo
|
Linagliptin
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
1343/3485 (38.54%) |
1293/3494 (37.01%) |
Blood and lymphatic system disorders |
|
|
Anaemia |
17/3485 (0.49%) |
19/3494 (0.54%) |
Lymphadenopathy |
1/3485 (0.03%) |
2/3494 (0.06%) |
Thrombocytopenia |
2/3485 (0.06%) |
1/3494 (0.03%) |
Autoimmune haemolytic anaemia |
1/3485 (0.03%) |
1/3494 (0.03%) |
Haemorrhagic anaemia |
0/3485 (0.00%) |
2/3494 (0.06%) |
Immune thrombocytopenic purpura |
1/3485 (0.03%) |
1/3494 (0.03%) |
Leukocytosis |
1/3485 (0.03%) |
1/3494 (0.03%) |
Pancytopenia |
2/3485 (0.06%) |
0/3494 (0.00%) |
Anaemia macrocytic |
1/3485 (0.03%) |
0/3494 (0.00%) |
Anaemia of malignant disease |
1/3485 (0.03%) |
0/3494 (0.00%) |
Eosinophilia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Febrile neutropenia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Hypochromic anaemia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Iron deficiency anaemia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Lymphadenitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Nephrogenic anaemia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Cardiac disorders |
|
|
Cardiac failure |
104/3485 (2.98%) |
104/3494 (2.98%) |
Cardiac failure congestive |
98/3485 (2.81%) |
77/3494 (2.20%) |
Angina unstable |
70/3485 (2.01%) |
77/3494 (2.20%) |
Acute myocardial infarction |
59/3485 (1.69%) |
78/3494 (2.23%) |
Myocardial infarction |
54/3485 (1.55%) |
47/3494 (1.35%) |
Angina pectoris |
25/3485 (0.72%) |
42/3494 (1.20%) |
Atrial fibrillation |
26/3485 (0.75%) |
34/3494 (0.97%) |
Coronary artery disease |
21/3485 (0.60%) |
26/3494 (0.74%) |
Cardiac failure chronic |
20/3485 (0.57%) |
24/3494 (0.69%) |
Cardiac arrest |
17/3485 (0.49%) |
25/3494 (0.72%) |
Myocardial ischaemia |
12/3485 (0.34%) |
20/3494 (0.57%) |
Acute coronary syndrome |
18/3485 (0.52%) |
12/3494 (0.34%) |
Left ventricular failure |
12/3485 (0.34%) |
13/3494 (0.37%) |
Atrial flutter |
11/3485 (0.32%) |
13/3494 (0.37%) |
Cardiogenic shock |
12/3485 (0.34%) |
8/3494 (0.23%) |
Atrioventricular block complete |
10/3485 (0.29%) |
9/3494 (0.26%) |
Cardiac failure acute |
7/3485 (0.20%) |
10/3494 (0.29%) |
Cardio-respiratory arrest |
8/3485 (0.23%) |
8/3494 (0.23%) |
Coronary artery stenosis |
8/3485 (0.23%) |
5/3494 (0.14%) |
Bradycardia |
6/3485 (0.17%) |
5/3494 (0.14%) |
Sinus node dysfunction |
4/3485 (0.11%) |
7/3494 (0.20%) |
Acute left ventricular failure |
8/3485 (0.23%) |
1/3494 (0.03%) |
Atrioventricular block second degree |
4/3485 (0.11%) |
5/3494 (0.14%) |
Coronary artery occlusion |
3/3485 (0.09%) |
6/3494 (0.17%) |
Arteriosclerosis coronary artery |
6/3485 (0.17%) |
2/3494 (0.06%) |
Atrioventricular block |
5/3485 (0.14%) |
2/3494 (0.06%) |
Ischaemic cardiomyopathy |
3/3485 (0.09%) |
4/3494 (0.11%) |
Ventricular tachycardia |
3/3485 (0.09%) |
3/3494 (0.09%) |
Cardiomyopathy |
2/3485 (0.06%) |
2/3494 (0.06%) |
Cardiopulmonary failure |
1/3485 (0.03%) |
3/3494 (0.09%) |
Ventricular fibrillation |
3/3485 (0.09%) |
1/3494 (0.03%) |
Arrhythmia |
1/3485 (0.03%) |
2/3494 (0.06%) |
Cardiovascular insufficiency |
1/3485 (0.03%) |
2/3494 (0.06%) |
Sinus bradycardia |
1/3485 (0.03%) |
2/3494 (0.06%) |
Supraventricular tachycardia |
2/3485 (0.06%) |
1/3494 (0.03%) |
Ventricular arrhythmia |
3/3485 (0.09%) |
0/3494 (0.00%) |
Aortic valve incompetence |
1/3485 (0.03%) |
1/3494 (0.03%) |
Bundle branch block left |
1/3485 (0.03%) |
1/3494 (0.03%) |
Cardiac disorder |
0/3485 (0.00%) |
2/3494 (0.06%) |
Cardiomegaly |
2/3485 (0.06%) |
0/3494 (0.00%) |
Diastolic dysfunction |
1/3485 (0.03%) |
1/3494 (0.03%) |
Mitral valve incompetence |
0/3485 (0.00%) |
2/3494 (0.06%) |
Myocardial fibrosis |
1/3485 (0.03%) |
1/3494 (0.03%) |
Pericardial effusion |
0/3485 (0.00%) |
2/3494 (0.06%) |
Silent myocardial infarction |
1/3485 (0.03%) |
1/3494 (0.03%) |
Sinus tachycardia |
1/3485 (0.03%) |
1/3494 (0.03%) |
Systolic dysfunction |
1/3485 (0.03%) |
1/3494 (0.03%) |
Adams-stokes syndrome |
1/3485 (0.03%) |
0/3494 (0.00%) |
Aortic valve disease |
0/3485 (0.00%) |
1/3494 (0.03%) |
Arrhythmia supraventricular |
1/3485 (0.03%) |
0/3494 (0.00%) |
Atrioventricular block first degree |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cardiac tamponade |
0/3485 (0.00%) |
1/3494 (0.03%) |
Cardiomyopathy acute |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cardiorenal syndrome |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cardiovascular disorder |
1/3485 (0.03%) |
0/3494 (0.00%) |
Chordae tendinae rupture |
1/3485 (0.03%) |
0/3494 (0.00%) |
Chronic left ventricular failure |
1/3485 (0.03%) |
0/3494 (0.00%) |
Conduction disorder |
0/3485 (0.00%) |
1/3494 (0.03%) |
Cyanosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Degenerative mitral valve disease |
0/3485 (0.00%) |
1/3494 (0.03%) |
Intracardiac thrombus |
1/3485 (0.03%) |
0/3494 (0.00%) |
Left ventricular dysfunction |
1/3485 (0.03%) |
0/3494 (0.00%) |
Mitral valve disease |
1/3485 (0.03%) |
0/3494 (0.00%) |
Mitral valve stenosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Myocardial necrosis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Myocarditis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Paroxysmal atrioventricular block |
1/3485 (0.03%) |
0/3494 (0.00%) |
Pericarditis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Pericarditis constrictive |
0/3485 (0.00%) |
1/3494 (0.03%) |
Pulseless electrical activity |
0/3485 (0.00%) |
1/3494 (0.03%) |
Sinus arrest |
1/3485 (0.03%) |
0/3494 (0.00%) |
Tachyarrhythmia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Tachycardia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Tricuspid valve incompetence |
0/3485 (0.00%) |
1/3494 (0.03%) |
Trifascicular block |
0/3485 (0.00%) |
1/3494 (0.03%) |
Ventricular extrasystoles |
1/3485 (0.03%) |
0/3494 (0.00%) |
Congenital, familial and genetic disorders |
|
|
Accessory spleen |
0/3485 (0.00%) |
1/3494 (0.03%) |
Atrial septal defect |
0/3485 (0.00%) |
1/3494 (0.03%) |
Cystic lymphangioma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Dermoid cyst |
1/3485 (0.03%) |
0/3494 (0.00%) |
Gastrointestinal arteriovenous malformation |
1/3485 (0.03%) |
0/3494 (0.00%) |
Hypertrophic cardiomyopathy |
1/3485 (0.03%) |
0/3494 (0.00%) |
Keratosis follicular |
1/3485 (0.03%) |
0/3494 (0.00%) |
Myocardial bridging |
0/3485 (0.00%) |
1/3494 (0.03%) |
Ear and labyrinth disorders |
|
|
Deafness neurosensory |
3/3485 (0.09%) |
4/3494 (0.11%) |
Vertigo |
4/3485 (0.11%) |
3/3494 (0.09%) |
Deafness |
2/3485 (0.06%) |
1/3494 (0.03%) |
Deafness bilateral |
2/3485 (0.06%) |
1/3494 (0.03%) |
Tinnitus |
3/3485 (0.09%) |
0/3494 (0.00%) |
Deafness unilateral |
0/3485 (0.00%) |
2/3494 (0.06%) |
Hypoacusis |
0/3485 (0.00%) |
2/3494 (0.06%) |
Vertigo positional |
1/3485 (0.03%) |
1/3494 (0.03%) |
Conductive deafness |
0/3485 (0.00%) |
1/3494 (0.03%) |
Sudden hearing loss |
1/3485 (0.03%) |
0/3494 (0.00%) |
Endocrine disorders |
|
|
Goitre |
2/3485 (0.06%) |
2/3494 (0.06%) |
Adrenal insufficiency |
1/3485 (0.03%) |
0/3494 (0.00%) |
Adrenal mass |
1/3485 (0.03%) |
0/3494 (0.00%) |
Hyperthyroidism |
0/3485 (0.00%) |
1/3494 (0.03%) |
Hypothyroidism |
1/3485 (0.03%) |
0/3494 (0.00%) |
Thyroid mass |
0/3485 (0.00%) |
1/3494 (0.03%) |
Eye disorders |
|
|
Cataract |
13/3485 (0.37%) |
11/3494 (0.31%) |
Glaucoma |
9/3485 (0.26%) |
6/3494 (0.17%) |
Vitreous haemorrhage |
5/3485 (0.14%) |
6/3494 (0.17%) |
Retinal detachment |
5/3485 (0.14%) |
4/3494 (0.11%) |
Diabetic retinopathy |
4/3485 (0.11%) |
3/3494 (0.09%) |
Macular hole |
2/3485 (0.06%) |
4/3494 (0.11%) |
Retinal vein occlusion |
1/3485 (0.03%) |
3/3494 (0.09%) |
Ulcerative keratitis |
2/3485 (0.06%) |
2/3494 (0.06%) |
Diplopia |
2/3485 (0.06%) |
1/3494 (0.03%) |
Macular degeneration |
2/3485 (0.06%) |
1/3494 (0.03%) |
Angle closure glaucoma |
1/3485 (0.03%) |
1/3494 (0.03%) |
Macular fibrosis |
1/3485 (0.03%) |
1/3494 (0.03%) |
Neovascular age-related macular degeneration |
2/3485 (0.06%) |
0/3494 (0.00%) |
Retinal haemorrhage |
2/3485 (0.06%) |
0/3494 (0.00%) |
Acquired corneal dystrophy |
1/3485 (0.03%) |
0/3494 (0.00%) |
Amaurosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Amaurosis fugax |
1/3485 (0.03%) |
0/3494 (0.00%) |
Blindness |
0/3485 (0.00%) |
1/3494 (0.03%) |
Blindness unilateral |
0/3485 (0.00%) |
1/3494 (0.03%) |
Cataract cortical |
0/3485 (0.00%) |
1/3494 (0.03%) |
Corneal decompensation |
0/3485 (0.00%) |
1/3494 (0.03%) |
Cystoid macular oedema |
0/3485 (0.00%) |
1/3494 (0.03%) |
Diabetic retinal oedema |
0/3485 (0.00%) |
1/3494 (0.03%) |
Dry age-related macular degeneration |
0/3485 (0.00%) |
1/3494 (0.03%) |
Hyalosis asteroid |
1/3485 (0.03%) |
0/3494 (0.00%) |
Macular oedema |
0/3485 (0.00%) |
1/3494 (0.03%) |
Open angle glaucoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Optic ischaemic neuropathy |
0/3485 (0.00%) |
1/3494 (0.03%) |
Retinal artery embolism |
0/3485 (0.00%) |
1/3494 (0.03%) |
Retinal artery occlusion |
0/3485 (0.00%) |
1/3494 (0.03%) |
Retinal degeneration |
1/3485 (0.03%) |
0/3494 (0.00%) |
Retinopathy |
0/3485 (0.00%) |
1/3494 (0.03%) |
Uveitis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Vitreous haematoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Gastrointestinal disorders |
|
|
Gastrointestinal haemorrhage |
11/3485 (0.32%) |
9/3494 (0.26%) |
Gastritis |
8/3485 (0.23%) |
5/3494 (0.14%) |
Upper gastrointestinal haemorrhage |
5/3485 (0.14%) |
8/3494 (0.23%) |
Diarrhoea |
2/3485 (0.06%) |
9/3494 (0.26%) |
Abdominal pain |
5/3485 (0.14%) |
5/3494 (0.14%) |
Pancreatitis acute |
3/3485 (0.09%) |
7/3494 (0.20%) |
Inguinal hernia |
5/3485 (0.14%) |
4/3494 (0.11%) |
Pancreatitis |
3/3485 (0.09%) |
6/3494 (0.17%) |
Vomiting |
3/3485 (0.09%) |
6/3494 (0.17%) |
Constipation |
4/3485 (0.11%) |
4/3494 (0.11%) |
Pancreatitis chronic |
6/3485 (0.17%) |
2/3494 (0.06%) |
Abdominal hernia |
5/3485 (0.14%) |
2/3494 (0.06%) |
Large intestine polyp |
3/3485 (0.09%) |
4/3494 (0.11%) |
Lower gastrointestinal haemorrhage |
3/3485 (0.09%) |
4/3494 (0.11%) |
Intestinal obstruction |
3/3485 (0.09%) |
3/3494 (0.09%) |
Colitis ischaemic |
1/3485 (0.03%) |
4/3494 (0.11%) |
Gastric ulcer |
2/3485 (0.06%) |
3/3494 (0.09%) |
Chronic gastritis |
1/3485 (0.03%) |
3/3494 (0.09%) |
Haematochezia |
2/3485 (0.06%) |
2/3494 (0.06%) |
Rectal haemorrhage |
2/3485 (0.06%) |
2/3494 (0.06%) |
Small intestinal obstruction |
2/3485 (0.06%) |
2/3494 (0.06%) |
Duodenal ulcer |
3/3485 (0.09%) |
0/3494 (0.00%) |
Duodenitis |
3/3485 (0.09%) |
0/3494 (0.00%) |
Haemorrhoids |
1/3485 (0.03%) |
2/3494 (0.06%) |
Hiatus hernia |
2/3485 (0.06%) |
1/3494 (0.03%) |
Melaena |
0/3485 (0.00%) |
3/3494 (0.09%) |
Pancreatic cyst |
3/3485 (0.09%) |
0/3494 (0.00%) |
Umbilical hernia |
3/3485 (0.09%) |
0/3494 (0.00%) |
Abdominal adhesions |
0/3485 (0.00%) |
2/3494 (0.06%) |
Abdominal wall haematoma |
1/3485 (0.03%) |
1/3494 (0.03%) |
Ascites |
1/3485 (0.03%) |
1/3494 (0.03%) |
Colitis |
0/3485 (0.00%) |
2/3494 (0.06%) |
Diverticulum intestinal |
1/3485 (0.03%) |
1/3494 (0.03%) |
Diverticulum intestinal haemorrhagic |
0/3485 (0.00%) |
2/3494 (0.06%) |
Dysphagia |
2/3485 (0.06%) |
0/3494 (0.00%) |
Enterocolitis |
1/3485 (0.03%) |
1/3494 (0.03%) |
Gastric haemorrhage |
1/3485 (0.03%) |
1/3494 (0.03%) |
Gastric polyps |
1/3485 (0.03%) |
1/3494 (0.03%) |
Gastrointestinal necrosis |
1/3485 (0.03%) |
1/3494 (0.03%) |
Gastrooesophageal reflux disease |
1/3485 (0.03%) |
1/3494 (0.03%) |
Ileus |
1/3485 (0.03%) |
1/3494 (0.03%) |
Incarcerated inguinal hernia |
1/3485 (0.03%) |
1/3494 (0.03%) |
Intestinal haemorrhage |
1/3485 (0.03%) |
1/3494 (0.03%) |
Intestinal perforation |
2/3485 (0.06%) |
0/3494 (0.00%) |
Irritable bowel syndrome |
1/3485 (0.03%) |
1/3494 (0.03%) |
Mesenteric artery thrombosis |
1/3485 (0.03%) |
1/3494 (0.03%) |
Nausea |
1/3485 (0.03%) |
1/3494 (0.03%) |
Obstructive pancreatitis |
1/3485 (0.03%) |
1/3494 (0.03%) |
Peptic ulcer |
2/3485 (0.06%) |
0/3494 (0.00%) |
Abdominal hernia obstructive |
0/3485 (0.00%) |
1/3494 (0.03%) |
Abdominal pain upper |
1/3485 (0.03%) |
0/3494 (0.00%) |
Abdominal tenderness |
0/3485 (0.00%) |
1/3494 (0.03%) |
Anal fissure |
0/3485 (0.00%) |
1/3494 (0.03%) |
Anal fistula |
1/3485 (0.03%) |
0/3494 (0.00%) |
Anal polyp |
1/3485 (0.03%) |
0/3494 (0.00%) |
Barrett's oesophagus |
0/3485 (0.00%) |
1/3494 (0.03%) |
Diabetic gastroparesis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Diverticulum |
1/3485 (0.03%) |
0/3494 (0.00%) |
Duodenal perforation |
0/3485 (0.00%) |
1/3494 (0.03%) |
Duodenal vascular ectasia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Duodenitis haemorrhagic |
0/3485 (0.00%) |
1/3494 (0.03%) |
Enteritis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Enterocolitis haemorrhagic |
0/3485 (0.00%) |
1/3494 (0.03%) |
Enterovesical fistula |
0/3485 (0.00%) |
1/3494 (0.03%) |
Faecaloma |
0/3485 (0.00%) |
1/3494 (0.03%) |
Gastric antral vascular ectasia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Gastric ulcer perforation |
1/3485 (0.03%) |
0/3494 (0.00%) |
Gastritis erosive |
0/3485 (0.00%) |
1/3494 (0.03%) |
Gastritis haemorrhagic |
0/3485 (0.00%) |
1/3494 (0.03%) |
Gastroduodenal ulcer |
1/3485 (0.03%) |
0/3494 (0.00%) |
Gastrointestinal obstruction |
1/3485 (0.03%) |
0/3494 (0.00%) |
Gastrointestinal perforation |
1/3485 (0.03%) |
0/3494 (0.00%) |
Haematemesis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Intestinal polyp |
1/3485 (0.03%) |
0/3494 (0.00%) |
Large intestinal obstruction |
0/3485 (0.00%) |
1/3494 (0.03%) |
Lip ulceration |
1/3485 (0.03%) |
0/3494 (0.00%) |
Mechanical ileus |
0/3485 (0.00%) |
1/3494 (0.03%) |
Mesenteric haemorrhage |
1/3485 (0.03%) |
0/3494 (0.00%) |
Oedema mouth |
0/3485 (0.00%) |
1/3494 (0.03%) |
Oesophageal varices haemorrhage |
1/3485 (0.03%) |
0/3494 (0.00%) |
Oesophagitis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Pancreatic failure |
0/3485 (0.00%) |
1/3494 (0.03%) |
Peritoneal adhesions |
1/3485 (0.03%) |
0/3494 (0.00%) |
Rectal polyp |
1/3485 (0.03%) |
0/3494 (0.00%) |
Retroperitoneal fibrosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Strangulated umbilical hernia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Tongue oedema |
0/3485 (0.00%) |
1/3494 (0.03%) |
Vomiting projectile |
1/3485 (0.03%) |
0/3494 (0.00%) |
General disorders |
|
|
Death |
23/3485 (0.66%) |
16/3494 (0.46%) |
Non-cardiac chest pain |
15/3485 (0.43%) |
15/3494 (0.43%) |
Sudden death |
20/3485 (0.57%) |
10/3494 (0.29%) |
Cardiac death |
5/3485 (0.14%) |
7/3494 (0.20%) |
Asthenia |
8/3485 (0.23%) |
2/3494 (0.06%) |
Chest pain |
4/3485 (0.11%) |
3/3494 (0.09%) |
Pyrexia |
2/3485 (0.06%) |
5/3494 (0.14%) |
Multiple organ dysfunction syndrome |
2/3485 (0.06%) |
3/3494 (0.09%) |
Generalised oedema |
1/3485 (0.03%) |
3/3494 (0.09%) |
Oedema peripheral |
3/3485 (0.09%) |
1/3494 (0.03%) |
Sudden cardiac death |
3/3485 (0.09%) |
1/3494 (0.03%) |
Chest discomfort |
1/3485 (0.03%) |
2/3494 (0.06%) |
Vascular stent restenosis |
1/3485 (0.03%) |
2/3494 (0.06%) |
Catheter site haemorrhage |
0/3485 (0.00%) |
2/3494 (0.06%) |
Chills |
0/3485 (0.00%) |
2/3494 (0.06%) |
Complication associated with device |
0/3485 (0.00%) |
2/3494 (0.06%) |
General physical health deterioration |
0/3485 (0.00%) |
2/3494 (0.06%) |
Necrobiosis |
0/3485 (0.00%) |
2/3494 (0.06%) |
Application site haemorrhage |
0/3485 (0.00%) |
1/3494 (0.03%) |
Chronic fatigue syndrome |
1/3485 (0.03%) |
0/3494 (0.00%) |
Fatigue |
1/3485 (0.03%) |
0/3494 (0.00%) |
Feeling abnormal |
0/3485 (0.00%) |
1/3494 (0.03%) |
Impaired healing |
1/3485 (0.03%) |
0/3494 (0.00%) |
Injection site haematoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Malaise |
1/3485 (0.03%) |
0/3494 (0.00%) |
Medical device site joint inflammation |
0/3485 (0.00%) |
1/3494 (0.03%) |
Peripheral swelling |
1/3485 (0.03%) |
0/3494 (0.00%) |
Strangulated hernia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Systemic inflammatory response syndrome |
0/3485 (0.00%) |
1/3494 (0.03%) |
Ulcer haemorrhage |
0/3485 (0.00%) |
1/3494 (0.03%) |
Vascular stent occlusion |
0/3485 (0.00%) |
1/3494 (0.03%) |
Hepatobiliary disorders |
|
|
Cholelithiasis |
9/3485 (0.26%) |
10/3494 (0.29%) |
Cholecystitis acute |
7/3485 (0.20%) |
10/3494 (0.29%) |
Cholecystitis |
3/3485 (0.09%) |
7/3494 (0.20%) |
Hepatic cirrhosis |
2/3485 (0.06%) |
5/3494 (0.14%) |
Hepatic failure |
2/3485 (0.06%) |
3/3494 (0.09%) |
Bile duct stone |
2/3485 (0.06%) |
2/3494 (0.06%) |
Biliary colic |
0/3485 (0.00%) |
2/3494 (0.06%) |
Cholangitis |
2/3485 (0.06%) |
0/3494 (0.00%) |
Cholecystitis chronic |
1/3485 (0.03%) |
1/3494 (0.03%) |
Hepatic steatosis |
0/3485 (0.00%) |
2/3494 (0.06%) |
Autoimmune hepatitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Bile duct obstruction |
0/3485 (0.00%) |
1/3494 (0.03%) |
Biliary dyspepsia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Biliary tract disorder |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cholangitis acute |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cirrhosis alcoholic |
1/3485 (0.03%) |
0/3494 (0.00%) |
Ischaemic hepatitis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Jaundice |
0/3485 (0.00%) |
1/3494 (0.03%) |
Portal hypertension |
0/3485 (0.00%) |
1/3494 (0.03%) |
Portal vein thrombosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Immune system disorders |
|
|
Hypersensitivity |
0/3485 (0.00%) |
2/3494 (0.06%) |
Drug hypersensitivity |
0/3485 (0.00%) |
1/3494 (0.03%) |
Overlap syndrome |
1/3485 (0.03%) |
0/3494 (0.00%) |
Infections and infestations |
|
|
Pneumonia |
121/3485 (3.47%) |
99/3494 (2.83%) |
Urinary tract infection |
41/3485 (1.18%) |
30/3494 (0.86%) |
Cellulitis |
38/3485 (1.09%) |
22/3494 (0.63%) |
Sepsis |
33/3485 (0.95%) |
18/3494 (0.52%) |
Bronchitis |
17/3485 (0.49%) |
8/3494 (0.23%) |
Osteomyelitis |
14/3485 (0.40%) |
11/3494 (0.31%) |
Septic shock |
12/3485 (0.34%) |
13/3494 (0.37%) |
Gangrene |
14/3485 (0.40%) |
10/3494 (0.29%) |
Gastroenteritis |
9/3485 (0.26%) |
11/3494 (0.31%) |
Localised infection |
7/3485 (0.20%) |
10/3494 (0.29%) |
Pyelonephritis |
3/3485 (0.09%) |
14/3494 (0.40%) |
Urosepsis |
7/3485 (0.20%) |
5/3494 (0.14%) |
Respiratory tract infection |
7/3485 (0.20%) |
3/3494 (0.09%) |
Diabetic foot infection |
6/3485 (0.17%) |
3/3494 (0.09%) |
Influenza |
2/3485 (0.06%) |
7/3494 (0.20%) |
Pyelonephritis acute |
3/3485 (0.09%) |
6/3494 (0.17%) |
Erysipelas |
4/3485 (0.11%) |
3/3494 (0.09%) |
Infected skin ulcer |
6/3485 (0.17%) |
1/3494 (0.03%) |
Lower respiratory tract infection |
4/3485 (0.11%) |
3/3494 (0.09%) |
Abscess limb |
4/3485 (0.11%) |
2/3494 (0.06%) |
Device related infection |
2/3485 (0.06%) |
4/3494 (0.11%) |
Peritonitis |
4/3485 (0.11%) |
2/3494 (0.06%) |
Upper respiratory tract infection |
2/3485 (0.06%) |
4/3494 (0.11%) |
Bacteraemia |
2/3485 (0.06%) |
3/3494 (0.09%) |
Necrotising fasciitis |
3/3485 (0.09%) |
2/3494 (0.06%) |
Postoperative wound infection |
2/3485 (0.06%) |
3/3494 (0.09%) |
Anal abscess |
4/3485 (0.11%) |
0/3494 (0.00%) |
Catheter site infection |
3/3485 (0.09%) |
1/3494 (0.03%) |
Diabetic gangrene |
3/3485 (0.09%) |
1/3494 (0.03%) |
Diverticulitis |
2/3485 (0.06%) |
2/3494 (0.06%) |
Lung infection |
1/3485 (0.03%) |
3/3494 (0.09%) |
Post procedural infection |
3/3485 (0.09%) |
1/3494 (0.03%) |
Subcutaneous abscess |
4/3485 (0.11%) |
0/3494 (0.00%) |
Appendicitis |
3/3485 (0.09%) |
0/3494 (0.00%) |
Arthritis bacterial |
2/3485 (0.06%) |
1/3494 (0.03%) |
Clostridium difficile colitis |
1/3485 (0.03%) |
2/3494 (0.06%) |
Endocarditis |
2/3485 (0.06%) |
1/3494 (0.03%) |
Escherichia sepsis |
1/3485 (0.03%) |
2/3494 (0.06%) |
Infection |
1/3485 (0.03%) |
2/3494 (0.06%) |
Pneumonia bacterial |
1/3485 (0.03%) |
2/3494 (0.06%) |
Pulmonary sepsis |
1/3485 (0.03%) |
2/3494 (0.06%) |
Soft tissue infection |
1/3485 (0.03%) |
2/3494 (0.06%) |
Bacterial infection |
1/3485 (0.03%) |
1/3494 (0.03%) |
Carbuncle |
1/3485 (0.03%) |
1/3494 (0.03%) |
Cholecystitis infective |
2/3485 (0.06%) |
0/3494 (0.00%) |
Device related sepsis |
1/3485 (0.03%) |
1/3494 (0.03%) |
Escherichia urinary tract infection |
1/3485 (0.03%) |
1/3494 (0.03%) |
Gastroenteritis viral |
0/3485 (0.00%) |
2/3494 (0.06%) |
Herpes zoster |
0/3485 (0.00%) |
2/3494 (0.06%) |
Intervertebral discitis |
0/3485 (0.00%) |
2/3494 (0.06%) |
Osteomyelitis chronic |
1/3485 (0.03%) |
1/3494 (0.03%) |
Paronychia |
2/3485 (0.06%) |
0/3494 (0.00%) |
Periodontitis |
2/3485 (0.06%) |
0/3494 (0.00%) |
Scrotal abscess |
0/3485 (0.00%) |
2/3494 (0.06%) |
Staphylococcal infection |
1/3485 (0.03%) |
1/3494 (0.03%) |
Staphylococcal sepsis |
1/3485 (0.03%) |
1/3494 (0.03%) |
Urinary tract infection fungal |
1/3485 (0.03%) |
1/3494 (0.03%) |
Wound infection |
2/3485 (0.06%) |
0/3494 (0.00%) |
Abdominal abscess |
1/3485 (0.03%) |
0/3494 (0.00%) |
Abdominal sepsis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Abdominal wall abscess |
0/3485 (0.00%) |
1/3494 (0.03%) |
Bacterial pyelonephritis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Bacterial sepsis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Blebitis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Bursitis infective |
1/3485 (0.03%) |
0/3494 (0.00%) |
Chikungunya virus infection |
1/3485 (0.03%) |
0/3494 (0.00%) |
Chronic sinusitis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Clostridium colitis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Clostridium difficile infection |
0/3485 (0.00%) |
1/3494 (0.03%) |
Cytomegalovirus infection |
1/3485 (0.03%) |
0/3494 (0.00%) |
Dengue fever |
1/3485 (0.03%) |
0/3494 (0.00%) |
Disseminated tuberculosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Endocarditis bacterial |
0/3485 (0.00%) |
1/3494 (0.03%) |
Enteritis infectious |
0/3485 (0.00%) |
1/3494 (0.03%) |
Epididymitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Escherichia bacteraemia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Fungal peritonitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Gastroenteritis norovirus |
0/3485 (0.00%) |
1/3494 (0.03%) |
Gastroenteritis shigella |
1/3485 (0.03%) |
0/3494 (0.00%) |
Gastrointestinal bacterial infection |
0/3485 (0.00%) |
1/3494 (0.03%) |
Gastrointestinal infection |
0/3485 (0.00%) |
1/3494 (0.03%) |
Gastrointestinal viral infection |
1/3485 (0.03%) |
0/3494 (0.00%) |
Graft infection |
1/3485 (0.03%) |
0/3494 (0.00%) |
Groin abscess |
1/3485 (0.03%) |
0/3494 (0.00%) |
H1n1 influenza |
0/3485 (0.00%) |
1/3494 (0.03%) |
Hepatitis c |
1/3485 (0.03%) |
0/3494 (0.00%) |
Hepatitis infectious mononucleosis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Histoplasmosis cutaneous |
1/3485 (0.03%) |
0/3494 (0.00%) |
Histoplasmosis disseminated |
0/3485 (0.00%) |
1/3494 (0.03%) |
Infected cyst |
1/3485 (0.03%) |
0/3494 (0.00%) |
Infected dermal cyst |
0/3485 (0.00%) |
1/3494 (0.03%) |
Infectious colitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Infective exacerbation of chronic obstructive airways disease |
1/3485 (0.03%) |
0/3494 (0.00%) |
Injection site abscess |
0/3485 (0.00%) |
1/3494 (0.03%) |
Intestinal sepsis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Klebsiella bacteraemia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Klebsiella infection |
0/3485 (0.00%) |
1/3494 (0.03%) |
Klebsiella sepsis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Laryngitis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Leptospirosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Liver abscess |
1/3485 (0.03%) |
0/3494 (0.00%) |
Lyme disease |
1/3485 (0.03%) |
0/3494 (0.00%) |
Mediastinitis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Medical device site cellulitis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Meningitis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Meningitis viral |
0/3485 (0.00%) |
1/3494 (0.03%) |
Mycoplasma infection |
0/3485 (0.00%) |
1/3494 (0.03%) |
Myiasis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Neutropenic sepsis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Nosocomial infection |
1/3485 (0.03%) |
0/3494 (0.00%) |
Oral candidiasis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Orchitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Osteomyelitis viral |
1/3485 (0.03%) |
0/3494 (0.00%) |
Otitis externa |
1/3485 (0.03%) |
0/3494 (0.00%) |
Otitis media |
1/3485 (0.03%) |
0/3494 (0.00%) |
Pelvic abscess |
1/3485 (0.03%) |
0/3494 (0.00%) |
Perineal abscess |
1/3485 (0.03%) |
0/3494 (0.00%) |
Peritonitis bacterial |
1/3485 (0.03%) |
0/3494 (0.00%) |
Peritonsillar abscess |
0/3485 (0.00%) |
1/3494 (0.03%) |
Pneumonia chlamydial |
1/3485 (0.03%) |
0/3494 (0.00%) |
Pneumonia klebsiella |
0/3485 (0.00%) |
1/3494 (0.03%) |
Pneumonia legionella |
0/3485 (0.00%) |
1/3494 (0.03%) |
Pneumonia pneumococcal |
0/3485 (0.00%) |
1/3494 (0.03%) |
Pseudomembranous colitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Pseudomonas infection |
0/3485 (0.00%) |
1/3494 (0.03%) |
Pulpitis dental |
1/3485 (0.03%) |
0/3494 (0.00%) |
Pyelonephritis chronic |
1/3485 (0.03%) |
0/3494 (0.00%) |
Renal abscess |
1/3485 (0.03%) |
0/3494 (0.00%) |
Respiratory tract infection viral |
1/3485 (0.03%) |
0/3494 (0.00%) |
Scrub typhus |
0/3485 (0.00%) |
1/3494 (0.03%) |
Sialoadenitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Skin infection |
1/3485 (0.03%) |
0/3494 (0.00%) |
Spinal cord abscess |
1/3485 (0.03%) |
0/3494 (0.00%) |
Streptococcal bacteraemia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Systemic infection |
1/3485 (0.03%) |
0/3494 (0.00%) |
Tonsillitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Tooth infection |
1/3485 (0.03%) |
0/3494 (0.00%) |
Tracheobronchitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Tuberculosis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Urinary tract infection bacterial |
1/3485 (0.03%) |
0/3494 (0.00%) |
Urinary tract infection pseudomonal |
0/3485 (0.00%) |
1/3494 (0.03%) |
Viraemia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Viral tonsillitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Injury, poisoning and procedural complications |
|
|
Fall |
25/3485 (0.72%) |
19/3494 (0.54%) |
Femur fracture |
6/3485 (0.17%) |
10/3494 (0.29%) |
Hip fracture |
7/3485 (0.20%) |
3/3494 (0.09%) |
Limb injury |
5/3485 (0.14%) |
5/3494 (0.14%) |
Road traffic accident |
7/3485 (0.20%) |
2/3494 (0.06%) |
Contusion |
3/3485 (0.09%) |
5/3494 (0.14%) |
Tibia fracture |
3/3485 (0.09%) |
4/3494 (0.11%) |
Humerus fracture |
3/3485 (0.09%) |
3/3494 (0.09%) |
Rib fracture |
1/3485 (0.03%) |
5/3494 (0.14%) |
Subdural haematoma |
1/3485 (0.03%) |
5/3494 (0.14%) |
Ankle fracture |
0/3485 (0.00%) |
5/3494 (0.14%) |
Femoral neck fracture |
3/3485 (0.09%) |
2/3494 (0.06%) |
Head injury |
3/3485 (0.09%) |
2/3494 (0.06%) |
Facial bones fracture |
3/3485 (0.09%) |
1/3494 (0.03%) |
Foot fracture |
1/3485 (0.03%) |
3/3494 (0.09%) |
Lower limb fracture |
2/3485 (0.06%) |
2/3494 (0.06%) |
Patella fracture |
1/3485 (0.03%) |
3/3494 (0.09%) |
Pelvic fracture |
2/3485 (0.06%) |
2/3494 (0.06%) |
Tendon rupture |
2/3485 (0.06%) |
2/3494 (0.06%) |
Wound dehiscence |
3/3485 (0.09%) |
1/3494 (0.03%) |
Craniocerebral injury |
1/3485 (0.03%) |
2/3494 (0.06%) |
Overdose |
2/3485 (0.06%) |
1/3494 (0.03%) |
Upper limb fracture |
3/3485 (0.09%) |
0/3494 (0.00%) |
Arteriovenous fistula site complication |
1/3485 (0.03%) |
1/3494 (0.03%) |
Back injury |
1/3485 (0.03%) |
1/3494 (0.03%) |
Fibula fracture |
1/3485 (0.03%) |
1/3494 (0.03%) |
Hyphaema |
1/3485 (0.03%) |
1/3494 (0.03%) |
Incisional hernia |
0/3485 (0.00%) |
2/3494 (0.06%) |
Joint dislocation |
1/3485 (0.03%) |
1/3494 (0.03%) |
Post procedural haemorrhage |
1/3485 (0.03%) |
1/3494 (0.03%) |
Subarachnoid haemorrhage |
1/3485 (0.03%) |
1/3494 (0.03%) |
Anastomotic complication |
0/3485 (0.00%) |
1/3494 (0.03%) |
Animal bite |
0/3485 (0.00%) |
1/3494 (0.03%) |
Arterial bypass occlusion |
0/3485 (0.00%) |
1/3494 (0.03%) |
Arteriovenous fistula thrombosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Bone contusion |
1/3485 (0.03%) |
0/3494 (0.00%) |
Brain contusion |
1/3485 (0.03%) |
0/3494 (0.00%) |
Burns second degree |
1/3485 (0.03%) |
0/3494 (0.00%) |
Carbon monoxide poisoning |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cervical vertebral fracture |
1/3485 (0.03%) |
0/3494 (0.00%) |
Chest injury |
1/3485 (0.03%) |
0/3494 (0.00%) |
Colon injury |
0/3485 (0.00%) |
1/3494 (0.03%) |
Coronary artery restenosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Endotracheal intubation complication |
0/3485 (0.00%) |
1/3494 (0.03%) |
Fracture displacement |
0/3485 (0.00%) |
1/3494 (0.03%) |
Hand fracture |
1/3485 (0.03%) |
0/3494 (0.00%) |
Heart injury |
1/3485 (0.03%) |
0/3494 (0.00%) |
Incomplete spinal fusion |
1/3485 (0.03%) |
0/3494 (0.00%) |
Injury |
1/3485 (0.03%) |
0/3494 (0.00%) |
Jaw fracture |
1/3485 (0.03%) |
0/3494 (0.00%) |
Joint injury |
0/3485 (0.00%) |
1/3494 (0.03%) |
Laceration |
1/3485 (0.03%) |
0/3494 (0.00%) |
Limb crushing injury |
0/3485 (0.00%) |
1/3494 (0.03%) |
Lumbar vertebral fracture |
1/3485 (0.03%) |
0/3494 (0.00%) |
Multiple injuries |
1/3485 (0.03%) |
0/3494 (0.00%) |
Muscle injury |
1/3485 (0.03%) |
0/3494 (0.00%) |
Muscle strain |
1/3485 (0.03%) |
0/3494 (0.00%) |
Periprocedural myocardial infarction |
1/3485 (0.03%) |
0/3494 (0.00%) |
Periprosthetic fracture |
1/3485 (0.03%) |
0/3494 (0.00%) |
Peritoneal dialysis complication |
0/3485 (0.00%) |
1/3494 (0.03%) |
Pneumothorax traumatic |
0/3485 (0.00%) |
1/3494 (0.03%) |
Post procedural complication |
1/3485 (0.03%) |
0/3494 (0.00%) |
Postoperative delirium |
0/3485 (0.00%) |
1/3494 (0.03%) |
Postoperative respiratory distress |
0/3485 (0.00%) |
1/3494 (0.03%) |
Procedural hypotension |
1/3485 (0.03%) |
0/3494 (0.00%) |
Procedural intestinal perforation |
1/3485 (0.03%) |
0/3494 (0.00%) |
Radius fracture |
0/3485 (0.00%) |
1/3494 (0.03%) |
Scar |
1/3485 (0.03%) |
0/3494 (0.00%) |
Skeletal injury |
1/3485 (0.03%) |
0/3494 (0.00%) |
Skull fractured base |
0/3485 (0.00%) |
1/3494 (0.03%) |
Spinal compression fracture |
0/3485 (0.00%) |
1/3494 (0.03%) |
Spinal fracture |
1/3485 (0.03%) |
0/3494 (0.00%) |
Splenic rupture |
1/3485 (0.03%) |
0/3494 (0.00%) |
Sternal fracture |
0/3485 (0.00%) |
1/3494 (0.03%) |
Stoma site polyp |
1/3485 (0.03%) |
0/3494 (0.00%) |
Stomal hernia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Subdural haemorrhage |
1/3485 (0.03%) |
0/3494 (0.00%) |
Thoracic vertebral fracture |
0/3485 (0.00%) |
1/3494 (0.03%) |
Traumatic intracranial haemorrhage |
0/3485 (0.00%) |
1/3494 (0.03%) |
Traumatic liver injury |
1/3485 (0.03%) |
0/3494 (0.00%) |
Ulna fracture |
1/3485 (0.03%) |
0/3494 (0.00%) |
Vascular pseudoaneurysm |
0/3485 (0.00%) |
1/3494 (0.03%) |
Vith nerve injury |
1/3485 (0.03%) |
0/3494 (0.00%) |
Wound |
1/3485 (0.03%) |
0/3494 (0.00%) |
Wound necrosis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Wrist fracture |
0/3485 (0.00%) |
1/3494 (0.03%) |
Investigations |
|
|
Glomerular filtration rate decreased |
30/3485 (0.86%) |
36/3494 (1.03%) |
Lipase increased |
5/3485 (0.14%) |
4/3494 (0.11%) |
Blood creatinine increased |
3/3485 (0.09%) |
1/3494 (0.03%) |
Blood pressure increased |
1/3485 (0.03%) |
2/3494 (0.06%) |
Arteriogram coronary |
0/3485 (0.00%) |
2/3494 (0.06%) |
Blood glucose increased |
0/3485 (0.00%) |
2/3494 (0.06%) |
Glycosylated haemoglobin increased |
2/3485 (0.06%) |
0/3494 (0.00%) |
Troponin increased |
1/3485 (0.03%) |
1/3494 (0.03%) |
Alanine aminotransferase increased |
1/3485 (0.03%) |
0/3494 (0.00%) |
Aspartate aminotransferase increased |
1/3485 (0.03%) |
0/3494 (0.00%) |
Aspiration bronchial |
1/3485 (0.03%) |
0/3494 (0.00%) |
Catheterisation cardiac |
0/3485 (0.00%) |
1/3494 (0.03%) |
Creatinine renal clearance decreased |
1/3485 (0.03%) |
0/3494 (0.00%) |
Echocardiogram |
0/3485 (0.00%) |
1/3494 (0.03%) |
Ejection fraction decreased |
0/3485 (0.00%) |
1/3494 (0.03%) |
Electrocardiogram qt prolonged |
1/3485 (0.03%) |
0/3494 (0.00%) |
Electrocardiogram t wave inversion |
0/3485 (0.00%) |
1/3494 (0.03%) |
Influenza a virus test positive |
0/3485 (0.00%) |
1/3494 (0.03%) |
International normalised ratio increased |
1/3485 (0.03%) |
0/3494 (0.00%) |
Intracardiac pressure increased |
0/3485 (0.00%) |
1/3494 (0.03%) |
Liver function test abnormal |
1/3485 (0.03%) |
0/3494 (0.00%) |
Liver function test increased |
0/3485 (0.00%) |
1/3494 (0.03%) |
Prostatic specific antigen increased |
1/3485 (0.03%) |
0/3494 (0.00%) |
Staphylococcus test positive |
1/3485 (0.03%) |
0/3494 (0.00%) |
Urine output decreased |
1/3485 (0.03%) |
0/3494 (0.00%) |
Metabolism and nutrition disorders |
|
|
Hypoglycaemia |
38/3485 (1.09%) |
28/3494 (0.80%) |
Hyperkalaemia |
19/3485 (0.55%) |
16/3494 (0.46%) |
Hyperglycaemia |
22/3485 (0.63%) |
12/3494 (0.34%) |
Dehydration |
6/3485 (0.17%) |
11/3494 (0.31%) |
Diabetes mellitus inadequate control |
10/3485 (0.29%) |
7/3494 (0.20%) |
Diabetes mellitus |
7/3485 (0.20%) |
9/3494 (0.26%) |
Fluid overload |
11/3485 (0.32%) |
5/3494 (0.14%) |
Diabetic metabolic decompensation |
5/3485 (0.14%) |
10/3494 (0.29%) |
Hyponatraemia |
5/3485 (0.14%) |
6/3494 (0.17%) |
Metabolic acidosis |
1/3485 (0.03%) |
7/3494 (0.20%) |
Diabetic ketoacidosis |
4/3485 (0.11%) |
3/3494 (0.09%) |
Electrolyte imbalance |
3/3485 (0.09%) |
3/3494 (0.09%) |
Hypokalaemia |
1/3485 (0.03%) |
3/3494 (0.09%) |
Type 2 diabetes mellitus |
0/3485 (0.00%) |
4/3494 (0.11%) |
Gout |
1/3485 (0.03%) |
2/3494 (0.06%) |
Hyperlipasaemia |
1/3485 (0.03%) |
2/3494 (0.06%) |
Hypovolaemia |
3/3485 (0.09%) |
0/3494 (0.00%) |
Lactic acidosis |
1/3485 (0.03%) |
2/3494 (0.06%) |
Fluid retention |
1/3485 (0.03%) |
1/3494 (0.03%) |
Hypercalcaemia |
1/3485 (0.03%) |
1/3494 (0.03%) |
Hypocalcaemia |
0/3485 (0.00%) |
2/3494 (0.06%) |
Abnormal loss of weight |
0/3485 (0.00%) |
1/3494 (0.03%) |
Acquired mixed hyperlipidaemia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Decreased appetite |
0/3485 (0.00%) |
1/3494 (0.03%) |
Diabetes with hyperosmolarity |
1/3485 (0.03%) |
0/3494 (0.00%) |
Failure to thrive |
0/3485 (0.00%) |
1/3494 (0.03%) |
Fluid imbalance |
0/3485 (0.00%) |
1/3494 (0.03%) |
Hypernatraemia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Hyperosmolar state |
1/3485 (0.03%) |
0/3494 (0.00%) |
Hyperphosphataemia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Hypertriglyceridaemia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Hyperuricaemia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Hypophagia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Obesity |
1/3485 (0.03%) |
0/3494 (0.00%) |
Vitamin d deficiency |
0/3485 (0.00%) |
1/3494 (0.03%) |
Musculoskeletal and connective tissue disorders |
|
|
Osteoarthritis |
17/3485 (0.49%) |
15/3494 (0.43%) |
Musculoskeletal chest pain |
6/3485 (0.17%) |
3/3494 (0.09%) |
Intervertebral disc protrusion |
2/3485 (0.06%) |
3/3494 (0.09%) |
Lumbar spinal stenosis |
4/3485 (0.11%) |
1/3494 (0.03%) |
Rhabdomyolysis |
2/3485 (0.06%) |
3/3494 (0.09%) |
Spinal osteoarthritis |
2/3485 (0.06%) |
3/3494 (0.09%) |
Arthritis |
1/3485 (0.03%) |
3/3494 (0.09%) |
Back pain |
1/3485 (0.03%) |
3/3494 (0.09%) |
Spinal column stenosis |
2/3485 (0.06%) |
2/3494 (0.06%) |
Intervertebral disc disorder |
1/3485 (0.03%) |
2/3494 (0.06%) |
Musculoskeletal pain |
1/3485 (0.03%) |
2/3494 (0.06%) |
Pain in extremity |
2/3485 (0.06%) |
1/3494 (0.03%) |
Polymyalgia rheumatica |
1/3485 (0.03%) |
2/3494 (0.06%) |
Spinal pain |
1/3485 (0.03%) |
2/3494 (0.06%) |
Spondylolisthesis |
1/3485 (0.03%) |
2/3494 (0.06%) |
Arthralgia |
1/3485 (0.03%) |
1/3494 (0.03%) |
Diabetic arthropathy |
2/3485 (0.06%) |
0/3494 (0.00%) |
Osteitis |
2/3485 (0.06%) |
0/3494 (0.00%) |
Plantar fasciitis |
1/3485 (0.03%) |
1/3494 (0.03%) |
Rotator cuff syndrome |
0/3485 (0.00%) |
2/3494 (0.06%) |
Ankylosing spondylitis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Arthritis reactive |
1/3485 (0.03%) |
0/3494 (0.00%) |
Bone pain |
1/3485 (0.03%) |
0/3494 (0.00%) |
Bursitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Exostosis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Fibromyalgia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Gouty arthritis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Intervertebral disc degeneration |
1/3485 (0.03%) |
0/3494 (0.00%) |
Joint range of motion decreased |
0/3485 (0.00%) |
1/3494 (0.03%) |
Limb discomfort |
0/3485 (0.00%) |
1/3494 (0.03%) |
Muscle haemorrhage |
1/3485 (0.03%) |
0/3494 (0.00%) |
Muscle spasms |
1/3485 (0.03%) |
0/3494 (0.00%) |
Myopathy |
0/3485 (0.00%) |
1/3494 (0.03%) |
Myopathy toxic |
1/3485 (0.03%) |
0/3494 (0.00%) |
Neck pain |
1/3485 (0.03%) |
0/3494 (0.00%) |
Neuropathic arthropathy |
0/3485 (0.00%) |
1/3494 (0.03%) |
Osteochondrosis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Osteonecrosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Pathological fracture |
0/3485 (0.00%) |
1/3494 (0.03%) |
Periostitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Rheumatoid arthritis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Synovial cyst |
1/3485 (0.03%) |
0/3494 (0.00%) |
Systemic lupus erythematosus |
1/3485 (0.03%) |
0/3494 (0.00%) |
Vertebral osteophyte |
0/3485 (0.00%) |
1/3494 (0.03%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Basal cell carcinoma |
14/3485 (0.40%) |
14/3494 (0.40%) |
Prostate cancer |
8/3485 (0.23%) |
9/3494 (0.26%) |
Squamous cell carcinoma of skin |
9/3485 (0.26%) |
8/3494 (0.23%) |
Lung neoplasm malignant |
5/3485 (0.14%) |
7/3494 (0.20%) |
Colon cancer |
7/3485 (0.20%) |
2/3494 (0.06%) |
Breast cancer |
4/3485 (0.11%) |
2/3494 (0.06%) |
Adenocarcinoma of colon |
4/3485 (0.11%) |
1/3494 (0.03%) |
Bladder cancer |
3/3485 (0.09%) |
2/3494 (0.06%) |
Bladder transitional cell carcinoma |
2/3485 (0.06%) |
2/3494 (0.06%) |
Hepatic cancer |
3/3485 (0.09%) |
1/3494 (0.03%) |
Invasive ductal breast carcinoma |
3/3485 (0.09%) |
1/3494 (0.03%) |
Lung adenocarcinoma |
1/3485 (0.03%) |
3/3494 (0.09%) |
Myelodysplastic syndrome |
3/3485 (0.09%) |
1/3494 (0.03%) |
Plasma cell myeloma |
2/3485 (0.06%) |
2/3494 (0.06%) |
Renal cancer |
1/3485 (0.03%) |
3/3494 (0.09%) |
Transitional cell carcinoma |
3/3485 (0.09%) |
1/3494 (0.03%) |
Bowen's disease |
2/3485 (0.06%) |
1/3494 (0.03%) |
Colon adenoma |
2/3485 (0.06%) |
1/3494 (0.03%) |
Hepatocellular carcinoma |
1/3485 (0.03%) |
2/3494 (0.06%) |
Metastases to bone |
2/3485 (0.06%) |
1/3494 (0.03%) |
Metastases to liver |
3/3485 (0.09%) |
0/3494 (0.00%) |
Non-hodgkin's lymphoma |
3/3485 (0.09%) |
0/3494 (0.00%) |
Rectal adenocarcinoma |
2/3485 (0.06%) |
1/3494 (0.03%) |
Adenocarcinoma gastric |
1/3485 (0.03%) |
1/3494 (0.03%) |
Adenocarcinoma pancreas |
2/3485 (0.06%) |
0/3494 (0.00%) |
Benign breast neoplasm |
1/3485 (0.03%) |
1/3494 (0.03%) |
Benign ovarian tumour |
2/3485 (0.06%) |
0/3494 (0.00%) |
Lung neoplasm |
0/3485 (0.00%) |
2/3494 (0.06%) |
Malignant melanoma |
1/3485 (0.03%) |
1/3494 (0.03%) |
Mediastinum neoplasm |
1/3485 (0.03%) |
1/3494 (0.03%) |
Meningioma |
0/3485 (0.00%) |
2/3494 (0.06%) |
Pancreatic carcinoma |
0/3485 (0.00%) |
2/3494 (0.06%) |
Plasmacytoma |
1/3485 (0.03%) |
1/3494 (0.03%) |
Prostate cancer metastatic |
0/3485 (0.00%) |
2/3494 (0.06%) |
Rectal cancer |
1/3485 (0.03%) |
1/3494 (0.03%) |
Renal neoplasm |
1/3485 (0.03%) |
1/3494 (0.03%) |
Small cell lung cancer |
1/3485 (0.03%) |
1/3494 (0.03%) |
Squamous cell carcinoma of lung |
1/3485 (0.03%) |
1/3494 (0.03%) |
Acute monocytic leukaemia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Acute myeloid leukaemia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Acute promyelocytic leukaemia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Basosquamous carcinoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Basosquamous carcinoma of skin |
0/3485 (0.00%) |
1/3494 (0.03%) |
Bladder neoplasm |
1/3485 (0.03%) |
0/3494 (0.00%) |
Brain neoplasm |
0/3485 (0.00%) |
1/3494 (0.03%) |
Bronchial carcinoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cancer pain |
1/3485 (0.03%) |
0/3494 (0.00%) |
Carcinoma in situ of penis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cardiac myxoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cardiac neoplasm unspecified |
0/3485 (0.00%) |
1/3494 (0.03%) |
Cervix carcinoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Chest wall tumour |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cholesteatoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Chronic lymphocytic leukaemia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Colon neoplasm |
1/3485 (0.03%) |
0/3494 (0.00%) |
Diffuse large b-cell lymphoma |
0/3485 (0.00%) |
1/3494 (0.03%) |
Endometrial adenocarcinoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Endometrial cancer |
0/3485 (0.00%) |
1/3494 (0.03%) |
Gallbladder cancer |
0/3485 (0.00%) |
1/3494 (0.03%) |
Gastric adenoma |
0/3485 (0.00%) |
1/3494 (0.03%) |
Gastric cancer |
1/3485 (0.03%) |
0/3494 (0.00%) |
Gastrointestinal cancer metastatic |
1/3485 (0.03%) |
0/3494 (0.00%) |
Gastrointestinal neoplasm |
1/3485 (0.03%) |
0/3494 (0.00%) |
Hepatic neoplasm |
1/3485 (0.03%) |
0/3494 (0.00%) |
Hodgkin's disease |
1/3485 (0.03%) |
0/3494 (0.00%) |
Intraductal proliferative breast lesion |
0/3485 (0.00%) |
1/3494 (0.03%) |
Laryngeal cancer |
0/3485 (0.00%) |
1/3494 (0.03%) |
Leiomyosarcoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Lip neoplasm malignant stage unspecified |
1/3485 (0.03%) |
0/3494 (0.00%) |
Lung adenocarcinoma stage 0 |
1/3485 (0.03%) |
0/3494 (0.00%) |
Lung cancer metastatic |
0/3485 (0.00%) |
1/3494 (0.03%) |
Lymphoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Malignant anorectal neoplasm |
1/3485 (0.03%) |
0/3494 (0.00%) |
Malignant melanoma in situ |
1/3485 (0.03%) |
0/3494 (0.00%) |
Malignant pleural effusion |
1/3485 (0.03%) |
0/3494 (0.00%) |
Metastases to lung |
0/3485 (0.00%) |
1/3494 (0.03%) |
Metastases to spine |
0/3485 (0.00%) |
1/3494 (0.03%) |
Metastatic carcinoma of the bladder |
1/3485 (0.03%) |
0/3494 (0.00%) |
Metastatic malignant melanoma |
0/3485 (0.00%) |
1/3494 (0.03%) |
Mucinous cystadenocarcinoma of pancreas |
1/3485 (0.03%) |
0/3494 (0.00%) |
Myeloproliferative neoplasm |
0/3485 (0.00%) |
1/3494 (0.03%) |
Naevoid melanoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Neoplasm skin |
1/3485 (0.03%) |
0/3494 (0.00%) |
Neuroendocrine tumour |
0/3485 (0.00%) |
1/3494 (0.03%) |
Non-small cell lung cancer |
0/3485 (0.00%) |
1/3494 (0.03%) |
Oesophageal adenocarcinoma |
0/3485 (0.00%) |
1/3494 (0.03%) |
Oesophageal carcinoma |
0/3485 (0.00%) |
1/3494 (0.03%) |
Oesophageal carcinoma recurrent |
1/3485 (0.03%) |
0/3494 (0.00%) |
Pancreatic carcinoma metastatic |
0/3485 (0.00%) |
1/3494 (0.03%) |
Pancreatic neoplasm |
0/3485 (0.00%) |
1/3494 (0.03%) |
Papillary renal cell carcinoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Papillary thyroid cancer |
1/3485 (0.03%) |
0/3494 (0.00%) |
Penile squamous cell carcinoma |
0/3485 (0.00%) |
1/3494 (0.03%) |
Prostatic adenoma |
0/3485 (0.00%) |
1/3494 (0.03%) |
Rectal adenoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Renal cell carcinoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Schwannoma |
0/3485 (0.00%) |
1/3494 (0.03%) |
Sebaceous adenoma |
0/3485 (0.00%) |
1/3494 (0.03%) |
Testis cancer |
0/3485 (0.00%) |
1/3494 (0.03%) |
Tongue cancer recurrent |
0/3485 (0.00%) |
1/3494 (0.03%) |
Tongue neoplasm malignant stage unspecified |
0/3485 (0.00%) |
1/3494 (0.03%) |
Transitional cell cancer of the renal pelvis and ureter |
0/3485 (0.00%) |
1/3494 (0.03%) |
Tumour of ampulla of vater |
0/3485 (0.00%) |
1/3494 (0.03%) |
Uterine leiomyoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Vulval cancer |
0/3485 (0.00%) |
1/3494 (0.03%) |
Vulval cancer stage 0 |
1/3485 (0.03%) |
0/3494 (0.00%) |
Nervous system disorders |
|
|
Ischaemic stroke |
49/3485 (1.41%) |
61/3494 (1.75%) |
Syncope |
25/3485 (0.72%) |
15/3494 (0.43%) |
Transient ischaemic attack |
9/3485 (0.26%) |
27/3494 (0.77%) |
Cerebrovascular accident |
12/3485 (0.34%) |
10/3494 (0.29%) |
Haemorrhagic stroke |
8/3485 (0.23%) |
10/3494 (0.29%) |
Dementia |
6/3485 (0.17%) |
8/3494 (0.23%) |
Diabetic neuropathy |
5/3485 (0.14%) |
7/3494 (0.20%) |
Seizure |
6/3485 (0.17%) |
5/3494 (0.14%) |
Cerebral infarction |
8/3485 (0.23%) |
2/3494 (0.06%) |
Presyncope |
7/3485 (0.20%) |
2/3494 (0.06%) |
Carotid artery stenosis |
6/3485 (0.17%) |
2/3494 (0.06%) |
Cerebral ischaemia |
4/3485 (0.11%) |
2/3494 (0.06%) |
Facial paralysis |
3/3485 (0.09%) |
2/3494 (0.06%) |
Headache |
4/3485 (0.11%) |
1/3494 (0.03%) |
Loss of consciousness |
3/3485 (0.09%) |
2/3494 (0.06%) |
Dizziness |
0/3485 (0.00%) |
4/3494 (0.11%) |
Encephalopathy |
2/3485 (0.06%) |
2/3494 (0.06%) |
Haemorrhage intracranial |
1/3485 (0.03%) |
3/3494 (0.09%) |
Hemiparesis |
4/3485 (0.11%) |
0/3494 (0.00%) |
Myelopathy |
3/3485 (0.09%) |
1/3494 (0.03%) |
Altered state of consciousness |
1/3485 (0.03%) |
2/3494 (0.06%) |
Cerebral haemorrhage |
1/3485 (0.03%) |
2/3494 (0.06%) |
Diabetic coma |
1/3485 (0.03%) |
2/3494 (0.06%) |
Epilepsy |
2/3485 (0.06%) |
1/3494 (0.03%) |
Hypertensive encephalopathy |
1/3485 (0.03%) |
2/3494 (0.06%) |
Lacunar infarction |
2/3485 (0.06%) |
1/3494 (0.03%) |
Basal ganglia infarction |
2/3485 (0.06%) |
0/3494 (0.00%) |
Brain oedema |
1/3485 (0.03%) |
1/3494 (0.03%) |
Brain stem infarction |
1/3485 (0.03%) |
1/3494 (0.03%) |
Carotid artery occlusion |
2/3485 (0.06%) |
0/3494 (0.00%) |
Cerebrovascular disorder |
2/3485 (0.06%) |
0/3494 (0.00%) |
Dementia with lewy bodies |
2/3485 (0.06%) |
0/3494 (0.00%) |
Embolic stroke |
1/3485 (0.03%) |
1/3494 (0.03%) |
Facial nerve disorder |
1/3485 (0.03%) |
1/3494 (0.03%) |
Hemiplegia |
0/3485 (0.00%) |
2/3494 (0.06%) |
Hypoglycaemic coma |
1/3485 (0.03%) |
1/3494 (0.03%) |
Hypoxic-ischaemic encephalopathy |
1/3485 (0.03%) |
1/3494 (0.03%) |
Intracranial aneurysm |
0/3485 (0.00%) |
2/3494 (0.06%) |
Ischaemic cerebral infarction |
1/3485 (0.03%) |
1/3494 (0.03%) |
Lumbar radiculopathy |
1/3485 (0.03%) |
1/3494 (0.03%) |
Neuropathy peripheral |
0/3485 (0.00%) |
2/3494 (0.06%) |
Parkinson's disease |
1/3485 (0.03%) |
1/3494 (0.03%) |
Partial seizures |
0/3485 (0.00%) |
2/3494 (0.06%) |
Sciatica |
0/3485 (0.00%) |
2/3494 (0.06%) |
Thrombotic stroke |
1/3485 (0.03%) |
1/3494 (0.03%) |
Vertebrobasilar insufficiency |
1/3485 (0.03%) |
1/3494 (0.03%) |
Brain injury |
1/3485 (0.03%) |
0/3494 (0.00%) |
Carotid arteriosclerosis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Carotid artery dissection |
1/3485 (0.03%) |
0/3494 (0.00%) |
Carotid sinus syndrome |
0/3485 (0.00%) |
1/3494 (0.03%) |
Carpal tunnel syndrome |
0/3485 (0.00%) |
1/3494 (0.03%) |
Central nervous system lesion |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cerebral haematoma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cerebral small vessel ischaemic disease |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cerebrospinal fluid leakage |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cervical radiculopathy |
0/3485 (0.00%) |
1/3494 (0.03%) |
Cervicobrachial syndrome |
1/3485 (0.03%) |
0/3494 (0.00%) |
Coma |
1/3485 (0.03%) |
0/3494 (0.00%) |
Complex regional pain syndrome |
1/3485 (0.03%) |
0/3494 (0.00%) |
Dyskinesia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Generalised tonic-clonic seizure |
1/3485 (0.03%) |
0/3494 (0.00%) |
Hepatic encephalopathy |
1/3485 (0.03%) |
0/3494 (0.00%) |
Incoherent |
1/3485 (0.03%) |
0/3494 (0.00%) |
Intracranial pressure increased |
0/3485 (0.00%) |
1/3494 (0.03%) |
Intraventricular haemorrhage |
1/3485 (0.03%) |
0/3494 (0.00%) |
Lacunar stroke |
0/3485 (0.00%) |
1/3494 (0.03%) |
Metabolic encephalopathy |
0/3485 (0.00%) |
1/3494 (0.03%) |
Multiple sclerosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Myasthenia gravis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Neuritis cranial |
0/3485 (0.00%) |
1/3494 (0.03%) |
Neuroglycopenia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Paraesthesia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Parkinsonism |
1/3485 (0.03%) |
0/3494 (0.00%) |
Peripheral sensory neuropathy |
1/3485 (0.03%) |
0/3494 (0.00%) |
Polyneuropathy |
1/3485 (0.03%) |
0/3494 (0.00%) |
Post stroke seizure |
0/3485 (0.00%) |
1/3494 (0.03%) |
Spinal claudication |
1/3485 (0.03%) |
0/3494 (0.00%) |
Spinal cord compression |
0/3485 (0.00%) |
1/3494 (0.03%) |
Spinal epidural haematoma |
0/3485 (0.00%) |
1/3494 (0.03%) |
Thalamic infarction |
1/3485 (0.03%) |
0/3494 (0.00%) |
Tremor |
1/3485 (0.03%) |
0/3494 (0.00%) |
Uraemic encephalopathy |
1/3485 (0.03%) |
0/3494 (0.00%) |
Vascular headache |
1/3485 (0.03%) |
0/3494 (0.00%) |
Vith nerve paralysis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Wernicke's encephalopathy |
1/3485 (0.03%) |
0/3494 (0.00%) |
Product Issues |
|
|
Device malfunction |
2/3485 (0.06%) |
2/3494 (0.06%) |
Device failure |
1/3485 (0.03%) |
0/3494 (0.00%) |
Psychiatric disorders |
|
|
Delirium |
4/3485 (0.11%) |
4/3494 (0.11%) |
Major depression |
3/3485 (0.09%) |
2/3494 (0.06%) |
Mental status changes |
3/3485 (0.09%) |
2/3494 (0.06%) |
Depression |
3/3485 (0.09%) |
1/3494 (0.03%) |
Anxiety |
2/3485 (0.06%) |
1/3494 (0.03%) |
Confusional state |
1/3485 (0.03%) |
1/3494 (0.03%) |
Hallucination, visual |
2/3485 (0.06%) |
0/3494 (0.00%) |
Acute stress disorder |
1/3485 (0.03%) |
0/3494 (0.00%) |
Adjustment disorder |
0/3485 (0.00%) |
1/3494 (0.03%) |
Affect lability |
0/3485 (0.00%) |
1/3494 (0.03%) |
Completed suicide |
1/3485 (0.03%) |
0/3494 (0.00%) |
Drug use disorder |
1/3485 (0.03%) |
0/3494 (0.00%) |
Insomnia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Irritability |
1/3485 (0.03%) |
0/3494 (0.00%) |
Mood disorder due to a general medical condition |
1/3485 (0.03%) |
0/3494 (0.00%) |
Psychotic disorder |
1/3485 (0.03%) |
0/3494 (0.00%) |
Suicidal ideation |
1/3485 (0.03%) |
0/3494 (0.00%) |
Renal and urinary disorders |
|
|
Acute kidney injury |
100/3485 (2.87%) |
96/3494 (2.75%) |
End stage renal disease |
45/3485 (1.29%) |
38/3494 (1.09%) |
Chronic kidney disease |
32/3485 (0.92%) |
49/3494 (1.40%) |
Renal failure |
31/3485 (0.89%) |
32/3494 (0.92%) |
Renal impairment |
27/3485 (0.77%) |
24/3494 (0.69%) |
Diabetic nephropathy |
7/3485 (0.20%) |
9/3494 (0.26%) |
Nephrolithiasis |
7/3485 (0.20%) |
5/3494 (0.14%) |
Urinary retention |
6/3485 (0.17%) |
5/3494 (0.14%) |
Haematuria |
4/3485 (0.11%) |
5/3494 (0.14%) |
Nephrotic syndrome |
2/3485 (0.06%) |
7/3494 (0.20%) |
Azotaemia |
6/3485 (0.17%) |
1/3494 (0.03%) |
Nephropathy |
4/3485 (0.11%) |
3/3494 (0.09%) |
Hydronephrosis |
1/3485 (0.03%) |
4/3494 (0.11%) |
Ureterolithiasis |
1/3485 (0.03%) |
4/3494 (0.11%) |
Urinary tract obstruction |
2/3485 (0.06%) |
2/3494 (0.06%) |
Calculus bladder |
0/3485 (0.00%) |
2/3494 (0.06%) |
Nephropathy toxic |
1/3485 (0.03%) |
1/3494 (0.03%) |
Renal artery stenosis |
1/3485 (0.03%) |
1/3494 (0.03%) |
Renal colic |
1/3485 (0.03%) |
1/3494 (0.03%) |
Renal mass |
1/3485 (0.03%) |
1/3494 (0.03%) |
Acute prerenal failure |
0/3485 (0.00%) |
1/3494 (0.03%) |
Anuria |
1/3485 (0.03%) |
0/3494 (0.00%) |
Bladder prolapse |
1/3485 (0.03%) |
0/3494 (0.00%) |
Dysuria |
1/3485 (0.03%) |
0/3494 (0.00%) |
Glomerulonephritis membranous |
0/3485 (0.00%) |
1/3494 (0.03%) |
Hypertensive nephropathy |
1/3485 (0.03%) |
0/3494 (0.00%) |
Mesangioproliferative glomerulonephritis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Oliguria |
1/3485 (0.03%) |
0/3494 (0.00%) |
Proteinuria |
1/3485 (0.03%) |
0/3494 (0.00%) |
Renal disorder |
1/3485 (0.03%) |
0/3494 (0.00%) |
Renal pain |
0/3485 (0.00%) |
1/3494 (0.03%) |
Renal tubular necrosis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Tubulointerstitial nephritis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Urethral haemorrhage |
0/3485 (0.00%) |
1/3494 (0.03%) |
Urinary incontinence |
1/3485 (0.03%) |
0/3494 (0.00%) |
Reproductive system and breast disorders |
|
|
Benign prostatic hyperplasia |
8/3485 (0.23%) |
4/3494 (0.11%) |
Acquired hydrocele |
0/3485 (0.00%) |
2/3494 (0.06%) |
Uterine polyp |
2/3485 (0.06%) |
0/3494 (0.00%) |
Acquired phimosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Cervical polyp |
1/3485 (0.03%) |
0/3494 (0.00%) |
Cystocele |
1/3485 (0.03%) |
0/3494 (0.00%) |
Endometrial hypertrophy |
1/3485 (0.03%) |
0/3494 (0.00%) |
Haemorrhagic ovarian cyst |
0/3485 (0.00%) |
1/3494 (0.03%) |
Vaginal haemorrhage |
1/3485 (0.03%) |
0/3494 (0.00%) |
Vaginal leukoplakia |
1/3485 (0.03%) |
0/3494 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Chronic obstructive pulmonary disease |
28/3485 (0.80%) |
21/3494 (0.60%) |
Dyspnoea |
16/3485 (0.46%) |
16/3494 (0.46%) |
Pulmonary oedema |
13/3485 (0.37%) |
16/3494 (0.46%) |
Acute pulmonary oedema |
15/3485 (0.43%) |
13/3494 (0.37%) |
Respiratory failure |
14/3485 (0.40%) |
13/3494 (0.37%) |
Pulmonary hypertension |
14/3485 (0.40%) |
12/3494 (0.34%) |
Pulmonary embolism |
12/3485 (0.34%) |
9/3494 (0.26%) |
Acute respiratory failure |
11/3485 (0.32%) |
9/3494 (0.26%) |
Pleural effusion |
11/3485 (0.32%) |
5/3494 (0.14%) |
Asthma |
3/3485 (0.09%) |
3/3494 (0.09%) |
Dyspnoea exertional |
5/3485 (0.14%) |
1/3494 (0.03%) |
Pulmonary fibrosis |
5/3485 (0.14%) |
1/3494 (0.03%) |
Hypoxia |
1/3485 (0.03%) |
4/3494 (0.11%) |
Epistaxis |
2/3485 (0.06%) |
2/3494 (0.06%) |
Pulmonary mass |
1/3485 (0.03%) |
3/3494 (0.09%) |
Respiratory arrest |
2/3485 (0.06%) |
2/3494 (0.06%) |
Haemoptysis |
1/3485 (0.03%) |
2/3494 (0.06%) |
Pneumonia aspiration |
1/3485 (0.03%) |
2/3494 (0.06%) |
Respiratory distress |
1/3485 (0.03%) |
2/3494 (0.06%) |
Sleep apnoea syndrome |
2/3485 (0.06%) |
1/3494 (0.03%) |
Asphyxia |
0/3485 (0.00%) |
2/3494 (0.06%) |
Chronic respiratory failure |
1/3485 (0.03%) |
1/3494 (0.03%) |
Cough |
1/3485 (0.03%) |
1/3494 (0.03%) |
Emphysema |
0/3485 (0.00%) |
2/3494 (0.06%) |
Lung disorder |
2/3485 (0.06%) |
0/3494 (0.00%) |
Pneumothorax |
2/3485 (0.06%) |
0/3494 (0.00%) |
Pulmonary congestion |
1/3485 (0.03%) |
1/3494 (0.03%) |
Wheezing |
0/3485 (0.00%) |
2/3494 (0.06%) |
Acute respiratory distress syndrome |
0/3485 (0.00%) |
1/3494 (0.03%) |
Aspiration |
0/3485 (0.00%) |
1/3494 (0.03%) |
Atelectasis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Bronchitis chronic |
1/3485 (0.03%) |
0/3494 (0.00%) |
Bronchospasm |
1/3485 (0.03%) |
0/3494 (0.00%) |
Eosinophilic pneumonia |
0/3485 (0.00%) |
1/3494 (0.03%) |
Haemothorax |
0/3485 (0.00%) |
1/3494 (0.03%) |
Interstitial lung disease |
0/3485 (0.00%) |
1/3494 (0.03%) |
Laryngeal oedema |
0/3485 (0.00%) |
1/3494 (0.03%) |
Mediastinal mass |
0/3485 (0.00%) |
1/3494 (0.03%) |
Mendelson's syndrome |
0/3485 (0.00%) |
1/3494 (0.03%) |
Paraneoplastic pleural effusion |
1/3485 (0.03%) |
0/3494 (0.00%) |
Pleural thickening |
1/3485 (0.03%) |
0/3494 (0.00%) |
Pneumonitis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Portopulmonary hypertension |
0/3485 (0.00%) |
1/3494 (0.03%) |
Restrictive pulmonary disease |
1/3485 (0.03%) |
0/3494 (0.00%) |
Sinus polyp |
1/3485 (0.03%) |
0/3494 (0.00%) |
Vocal cord cyst |
1/3485 (0.03%) |
0/3494 (0.00%) |
Vocal cord disorder |
1/3485 (0.03%) |
0/3494 (0.00%) |
Vocal cord polyp |
0/3485 (0.00%) |
1/3494 (0.03%) |
Skin and subcutaneous tissue disorders |
|
|
Diabetic foot |
24/3485 (0.69%) |
21/3494 (0.60%) |
Skin ulcer |
10/3485 (0.29%) |
7/3494 (0.20%) |
Angioedema |
1/3485 (0.03%) |
2/3494 (0.06%) |
Ischaemic skin ulcer |
2/3485 (0.06%) |
1/3494 (0.03%) |
Pemphigoid |
0/3485 (0.00%) |
3/3494 (0.09%) |
Pruritus |
0/3485 (0.00%) |
2/3494 (0.06%) |
Stasis dermatitis |
2/3485 (0.06%) |
0/3494 (0.00%) |
Decubitus ulcer |
0/3485 (0.00%) |
1/3494 (0.03%) |
Dermal cyst |
0/3485 (0.00%) |
1/3494 (0.03%) |
Dermatitis bullous |
0/3485 (0.00%) |
1/3494 (0.03%) |
Dermatitis exfoliative generalised |
0/3485 (0.00%) |
1/3494 (0.03%) |
Ecchymosis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Ichthyosis acquired |
0/3485 (0.00%) |
1/3494 (0.03%) |
Lentigo |
0/3485 (0.00%) |
1/3494 (0.03%) |
Necrobiosis lipoidica diabeticorum |
1/3485 (0.03%) |
0/3494 (0.00%) |
Neurodermatitis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Rash |
0/3485 (0.00%) |
1/3494 (0.03%) |
Rash maculo-papular |
1/3485 (0.03%) |
0/3494 (0.00%) |
Skin necrosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Skin ulcer haemorrhage |
0/3485 (0.00%) |
1/3494 (0.03%) |
Swelling face |
0/3485 (0.00%) |
1/3494 (0.03%) |
Toxic epidermal necrolysis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Social circumstances |
|
|
Homicide |
0/3485 (0.00%) |
1/3494 (0.03%) |
Limb prosthesis user |
0/3485 (0.00%) |
1/3494 (0.03%) |
Surgical and medical procedures |
|
|
Coronary revascularisation |
1/3485 (0.03%) |
2/3494 (0.06%) |
Hospitalisation |
0/3485 (0.00%) |
1/3494 (0.03%) |
Peripheral endarterectomy |
1/3485 (0.03%) |
0/3494 (0.00%) |
Vascular disorders |
|
|
Hypertension |
18/3485 (0.52%) |
32/3494 (0.92%) |
Hypertensive crisis |
20/3485 (0.57%) |
16/3494 (0.46%) |
Peripheral arterial occlusive disease |
17/3485 (0.49%) |
18/3494 (0.52%) |
Deep vein thrombosis |
14/3485 (0.40%) |
12/3494 (0.34%) |
Peripheral artery occlusion |
12/3485 (0.34%) |
5/3494 (0.14%) |
Peripheral ischaemia |
11/3485 (0.32%) |
5/3494 (0.14%) |
Aortic stenosis |
5/3485 (0.14%) |
8/3494 (0.23%) |
Peripheral vascular disorder |
7/3485 (0.20%) |
6/3494 (0.17%) |
Extremity necrosis |
9/3485 (0.26%) |
3/3494 (0.09%) |
Hypotension |
7/3485 (0.20%) |
5/3494 (0.14%) |
Peripheral artery stenosis |
4/3485 (0.11%) |
3/3494 (0.09%) |
Orthostatic hypotension |
0/3485 (0.00%) |
6/3494 (0.17%) |
Aortic aneurysm |
1/3485 (0.03%) |
4/3494 (0.11%) |
Hypovolaemic shock |
1/3485 (0.03%) |
4/3494 (0.11%) |
Venous thrombosis limb |
2/3485 (0.06%) |
3/3494 (0.09%) |
Arteriosclerosis |
3/3485 (0.09%) |
1/3494 (0.03%) |
Hypertensive emergency |
2/3485 (0.06%) |
2/3494 (0.06%) |
Circulatory collapse |
1/3485 (0.03%) |
2/3494 (0.06%) |
Accelerated hypertension |
1/3485 (0.03%) |
1/3494 (0.03%) |
Angiopathy |
1/3485 (0.03%) |
1/3494 (0.03%) |
Diabetic macroangiopathy |
2/3485 (0.06%) |
0/3494 (0.00%) |
Dry gangrene |
1/3485 (0.03%) |
1/3494 (0.03%) |
Haematoma |
2/3485 (0.06%) |
0/3494 (0.00%) |
Intermittent claudication |
0/3485 (0.00%) |
2/3494 (0.06%) |
Peripheral embolism |
2/3485 (0.06%) |
0/3494 (0.00%) |
Thrombophlebitis |
1/3485 (0.03%) |
1/3494 (0.03%) |
Thrombophlebitis superficial |
0/3485 (0.00%) |
2/3494 (0.06%) |
Varicose ulceration |
0/3485 (0.00%) |
2/3494 (0.06%) |
Aortic aneurysm rupture |
1/3485 (0.03%) |
0/3494 (0.00%) |
Aortic thrombosis |
1/3485 (0.03%) |
0/3494 (0.00%) |
Arterial insufficiency |
0/3485 (0.00%) |
1/3494 (0.03%) |
Arterial rupture |
0/3485 (0.00%) |
1/3494 (0.03%) |
Arteriovenous fistula |
1/3485 (0.03%) |
0/3494 (0.00%) |
Blood pressure inadequately controlled |
0/3485 (0.00%) |
1/3494 (0.03%) |
Diabetic vascular disorder |
0/3485 (0.00%) |
1/3494 (0.03%) |
Distributive shock |
1/3485 (0.03%) |
0/3494 (0.00%) |
Embolism |
1/3485 (0.03%) |
0/3494 (0.00%) |
Embolism arterial |
0/3485 (0.00%) |
1/3494 (0.03%) |
Embolism venous |
0/3485 (0.00%) |
1/3494 (0.03%) |
Femoral artery aneurysm |
0/3485 (0.00%) |
1/3494 (0.03%) |
Iliac artery occlusion |
0/3485 (0.00%) |
1/3494 (0.03%) |
Orthostatic hypertension |
1/3485 (0.03%) |
0/3494 (0.00%) |
Peripheral artery thrombosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Peripheral venous disease |
0/3485 (0.00%) |
1/3494 (0.03%) |
Shock |
1/3485 (0.03%) |
0/3494 (0.00%) |
Subclavian artery stenosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Systolic hypertension |
1/3485 (0.03%) |
0/3494 (0.00%) |
Thrombosis |
0/3485 (0.00%) |
1/3494 (0.03%) |
Vascular insufficiency |
1/3485 (0.03%) |
0/3494 (0.00%) |
Vein rupture |
1/3485 (0.03%) |
0/3494 (0.00%) |
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Placebo
|
Linagliptin
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
1422/3485 (40.80%) |
1434/3494 (41.04%) |
Infections and infestations |
|
|
Urinary tract infection |
162/3485 (4.65%) |
196/3494 (5.61%) |
Investigations |
|
|
Glomerular filtration rate decreased |
200/3485 (5.74%) |
202/3494 (5.78%) |
Metabolism and nutrition disorders |
|
|
Hypoglycaemia |
1003/3485 (28.78%) |
1022/3494 (29.25%) |
Hyperglycaemia |
240/3485 (6.89%) |
208/3494 (5.95%) |
Vascular disorders |
|
|
Hypertension |
232/3485 (6.66%) |
216/3494 (6.18%) |
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
|