Table 2 Crude and adjusted event rates of effectiveness and safety outcomes for edoxaban vs phenprocoumon
Outcome | Edoxaban | Phenprocoumon | |||||||
|---|---|---|---|---|---|---|---|---|---|
Patients with events | Person-years of follow-up | Crude rate per 100 person-years | Adjusted rate per 100 person-years | Patients with events | Person-years of follow-up | Crude rate per 100 person-years | Adjusted rate per 100 person-years | ||
Effectiveness | Stroke/SE | 158 | 8,101 | 2.0 | 1.7 | 421 | 19,323 | 2.2 | 1.8 |
All strokes | 138 | 8,108 | 1.7 | 1.5 | 356 | 19,373 | 1.8 | 1.6 | |
Ischemic stroke | 119 | 8,111 | 1.5 | 1.3 | 266 | 19,388 | 1.4 | 1.2 | |
Hemorrhagic stroke | 23 | 8,157 | 0.3 | 0.2 | 96 | 19,491 | 0.5 | 0.4 | |
All-cause mortality | 561 | 8,161 | 6.9 | 4.5 | 1,477 | 19,506 | 7.6 | 4.4 | |
Safety | Major bleeding | 191 | 8,105 | 2.4 | 2.1 | 696 | 19,172 | 3.6 | 2.9 |
Intracranial bleeding | 43 | 8,152 | 0.5 | 0.5 | 206 | 19,445 | 1.1 | 0.9 | |
Gastrointestinal bleeding | 254 | 8,056 | 3.2 | 2.8 | 567 | 19,127 | 3.0 | 2.3 | |
Any bleeding | 837 | 7,801 | 10.7 | 10.5 | 2,547 | 17,666 | 14.4 | 12.4 | |