| Incident oral FXai users | Oral FXai users with incident ICH |
---|---|---|
N | 78,086 | 530 |
Age at index date, mean (SD) [years] | 69.9 (13.4) | 77.4 (9.1) |
Age groups, [n, %] | ||
   < 45 | 4122 (5.3%) | 1 (0.2%) |
   45–64 | 19,061 (24.4%) | 52 (9.8%) |
   65–74 | 19,028 (24.4%) | 98 (18.5%) |
   75–84 | 28,324 (36.3%) | 256 (48.3%) |
   ≥ 85 | 7551 (9.7%) | 123 (23.2%) |
Gender, [n, %] | ||
   Male | 45,256 (58.0%) | 309 (58.3%) |
   Female | 32,830 (42.0%) | 221 (41.7%) |
DOAC indications, [n, %] | ||
   Venous thromboembolism | 26,656 (34.1%) | 122 (23.0%) |
   Atrial fibrillation | 56,826 (72.8%) | 457 (86.2%) |
   Non-mechanical cardiac-valve replacement | 2242 (2.9%) | 20 (3.8%) |
Comorbidities, [n, %] | ||
   Updated Charlson Comorbidity Index (mean, [SD]) | 2.4 (2.2) | 3.7 (2.4) |
   Diabetes type 1 | 2324 (3.0%) | 20 (3.8%) |
   Diabetes type 2 | 23,334 (29.9%) | 215 (40.6%) |
   Chronic kidney disease | 18,422 (23.6%) | 208 (39.3%) |
   Hypercholesterolemia | 21,762 (27.9%) | 175 (33.0%) |
   Hypertension | 62,449 (80.0%) | 486 (91.7%) |
   Coronary artery disease | 26,082 (33.4%) | 244 (46.0%) |
   Stroke | 10,428 (13.4%) | 151 (28.5%) |
   - Ischemic stroke | 8545 (10.9%) | 123 (23.2%) |
   - Haemorrhagic stroke | 734 (0.9%) | 29 (5.5%) |
   - Transitory ischemic attack | 3180 (4.1%) | 44 (8.3%) |
   Heart failure | 26,444 (33.9%) | 263 (49.6%) |
Major bleeding history > 60 days prior to FXai start | 3671 (4.7%) | 50 (9.43%) |
   Gastrointestinal diseases | 43,898 (56.2%) | 334 (63.0%) |
   Anaemia | 8788 (11.3%) | 93 (17.6%) |
   Urological diseases | 27,866 (35.7%) | 245 (46.2%) |
Comedications, [n, %] | ||
   History of non-FXai AC use | 7339 (9.4%) | 29 (5.5%) |
   Lipid lowering therapies | 26,681 (34.2%) | 266 (50.2%) |
   Anticancer therapies | 1554 (2.0%) | 17 (3.2%) |
   NSAIDs | 26,836 (34.4%) | 154 (29.1%) |
   Antiplatelet drugs | 14,273 (18.3%) | 95 (17.9%) |
   Antidepressants | 10,341 (13.2%) | 110 (20.8%) |
   Antivirals | 1251 (1.6%) | 11 (2.1%) |
   Corticosteroids | 10,533 (13.5%) | 53 (10.0%) |
   Gastroprotective agents | 28,354 (36.3%) | 252 (47.6%) |
   Hormone therapies | 1290 (1.7%) | 12 (2.3%) |
   Macrolides | 4266 (5.5%) | 20 (3.8%) |