TABLE 1.
Clinical characteristics of patients with hemorrhagic events.
| Characteristic | N = 1,2741 |
|---|---|
| Regimen | |
| Combination therapy | 352 (28%) |
| Monotherapy | 922 (72%) |
| Age | |
| <18 | 7 (0.5%) |
| ≥75 | 94 (7.4%) |
| 18–44 | 108 (8.5%) |
| 45–64 | 544 (43%) |
| 65–74 | 198 (16%) |
| Unknown | 323 (25%) |
| Sex | |
| F | 1,051 (82%) |
| M | 99 (7.8%) |
| Unknown | 124 (9.7%) |
| OUTC_COD | |
| CA | 1 (<0.1%) |
| DE | 294 (23%) |
| DS | 18 (1.4%) |
| HO | 477 (37%) |
| LT | 23 (1.8%) |
| OT | 457 (36%) |
| Unknown | 4 (0.3%) |
| soc_name | |
| Eye disorders | 83 (6.5%) |
| Gastrointestinal disorders | 661 (52%) |
| Hepatobiliary disorders | 4 (0.3%) |
| Neoplasms benign, malignant and unspecified | 59 (4.6%) |
| Nervous system disorders | 175 (14%) |
| Renal and urinary disorders | 39 (3.1%) |
| Reproductive system and breast disorders | 8 (0.6%) |
| Respiratory, thoracic and mediastinal disorders | 37 (2.9%) |
| Vascular disorders | 208 (16%) |
| pt_name | |
| Anal haemorrhage | 7 (0.5%) |
| Arterial haemorrhage | 1 (<0.1%) |
| Bronchial haemorrhage | 3 (0.2%) |
| Central nervous system haemorrhage | 3 (0.2%) |
| Cerebral haemorrhage | 107 (8.4%) |
| Cerebral microhaemorrhage | 1 (<0.1%) |
| Conjunctival haemorrhage | 9 (0.7%) |
| Cystitis haemorrhagic | 27 (2.1%) |
| Diarrhoea haemorrhagic | 46 (3.6%) |
| Duodenal ulcer haemorrhage | 8 (0.6%) |
| Enterocolitis haemorrhagic | 7 (0.5%) |
| Eye haemorrhage | 44 (3.5%) |
| Gastric haemorrhage | 43 (3.4%) |
| Gastritis haemorrhagic | 5 (0.4%) |
| Gastroduodenal haemorrhage | 2 (0.2%) |
| Gastrointestinal haemorrhage | 214 (17%) |
| Haemorrhage | 191 (15%) |
| Haemorrhage intracranial | 26 (2.0%) |
| Haemorrhage urinary tract | 4 (0.3%) |
| Haemorrhagic ascites | 2 (0.2%) |
| Haemorrhagic stroke | 12 (0.9%) |
| Haemorrhoidal haemorrhage | 21 (1.6%) |
| Haemorrhoids | 41 (3.2%) |
| Hepatic haemorrhage | 4 (0.3%) |
| Internal haemorrhage | 7 (0.5%) |
| Intestinal haemorrhage | 22 (1.7%) |
| Intra-abdominal haemorrhage | 1 (<0.1%) |
| Intracranial tumour haemorrhage | 10 (0.8%) |
| Intraventricular haemorrhage | 6 (0.5%) |
| Laryngeal haemorrhage | 1 (<0.1%) |
| Lip haemorrhage | 3 (0.2%) |
| Mouth haemorrhage | 35 (2.7%) |
| Naevus haemorrhage | 6 (0.5%) |
| Oesophageal haemorrhage | 5 (0.4%) |
| Oesophageal varices haemorrhage | 9 (0.7%) |
| Oesophagitis haemorrhagic | 1 (<0.1%) |
| Optic disc haemorrhage | 1 (<0.1%) |
| Pulmonary haemorrhage | 27 (2.1%) |
| Rectal haemorrhage | 186 (15%) |
| Renal haemorrhage | 1 (<0.1%) |
| Respiratory tract haemorrhage | 5 (0.4%) |
| Retinal haemorrhage | 29 (2.3%) |
| Retroperitoneal haemorrhage | 3 (0.2%) |
| Shock haemorrhagic | 7 (0.5%) |
| Subarachnoid haemorrhage | 19 (1.5%) |
| Thalamus haemorrhage | 1 (<0.1%) |
| Thoracic haemorrhage | 1 (<0.1%) |
| Tumour haemorrhage | 43 (3.4%) |
| Ureteric haemorrhage | 1 (<0.1%) |
| Urethral haemorrhage | 1 (<0.1%) |
| Urinary bladder haemorrhage | 5 (0.4%) |
| Uterine haemorrhage | 8 (0.6%) |
| Venous haemorrhage | 2 (0.2%) |