Table 4.
Safety and effectiveness outcomes in patients with a specific background
| Safety outcomes: Bleeding events | Effectiveness outcomes | |||||
|---|---|---|---|---|---|---|
| All bleeding | Major bleeding | Ischemic stroke (excluding TIA) or systemic embolism | ||||
| (%) | (n/N) | % | (n/N) | % | (n/N) | |
| All patients | 6.52 | (612/9391) | 1.13 | (106/9391) | 1.19 | (111/9351) |
| Advanced age (≥75 years) | 7.83 | (391/4996) | 1.44 | (72/4996) | 1.37 | (68/4974) |
| Low body weight (≤60 kg) | 6.48 | (380/5862) | 1.16 | (68/5862) | 1.13 | (66/5833) |
| Severely low body weight (<40 kg) | 9.26 | (34/367) | 3.00 | (11/367) | 1.92 | (7/364) |
| CLcr (≤50 mL/min) | 7.69 | (261/3396) | 1.71 | (58/3396) | 1.48 | (50/3377) |
| Liver dysfunction | 9.32 | (67/719) | 1.53 | (11/719) | 1.40 | (10/714) |
| Hypertension | 6.98 | (471/6744) | 1.23 | (83/6744) | 1.24 | (83/6719) |
| Heart disease | 8.36 | (311/3721) | 1.59 | (59/3721) | 1.19 | (44/3690) |
| Cerebrovascular disease | 7.60 | (153/2012) | 1.89 | (38/2012) | 2.74 | (55/2004) |
| Cancer | 14.25 | (104/730) | 1.64 | (12/730) | 1.52 | (11/723) |
| P‐gp inhibitor use a | 8.07 | (51/632) | 1.74 | (11/632) | 1.59 | (10/628) |
| Antiplatelet agent use | 11.87 | (150/1264) | 1.82 | (23/1264) | 2.56 | (32/1252) |
| DAPT use b | 21.74 | (35/161) | 4.35 | (7/161) | 4.97 | (8/161) |
a
P‐gp inhibitors, quinidine, verapamil, erythromycin, or cyclosporine.
b
DAPT, Dual antiplatelet therapy.