Table 2 Numbers and rates of outcome events
| Â | Â | Frailty category | ||||
|---|---|---|---|---|---|---|
All | Fit | Pre-frail | Mild-moderate | Severe | ||
Primary end points | ||||||
 Time to the first adjudicated stroke or systemic embolism | Warfarin | 333 | 55 | 185 | 83 | 10 |
1.73 (1.54 - 1.92) | 1.29 (0.95 - 1.63) | 1.61 (1.38 - 1.84) | 2.58 (2.03 - 3.14) | 3.40 (1.29 - 5.51) | ||
Edoxaban 30mg | 378 | 56 | 219 | 100 | 3 | |
1.95 (1.76 - 2.15) | 1.34 (0.99 - 1.69) | 1.90 (1.64 - 2.15) | 3.00 (2.41 - 3.59) | 1.04 (0.00 - 2.21) | ||
Edoxaban 60mg | 286 | 58 | 151 | 71 | 6 | |
1.47 (1.30 - 1.64) | 1.35 (1.00 - 1.70) | 1.31 (1.11 - 1.52) | 2.13 (1.64 - 2.63) | 1.85 (0.37 - 3.34) | ||
 Time to the first adjudicated major bleeding during treatment | Warfarin | 522 | 84 | 298 | 122 | 18 |
2.76 (2.52 - 3.00) | 2.01 (1.58 - 2.44) | 2.64 (2.34 - 2.95) | 3.85 (3.17 - 4.53) | 6.39 (3.44 - 9.35) | ||
Edoxaban 30mg | 249 | 35 | 141 | 60 | 13 | |
1.28 (1.12 - 1.44) | 0.83 (0.56 - 1.11) | 1.22 (1.02 - 1.42) | 1.80 (1.34 - 2.25) | 4.74 (2.16 - 7.31) | ||
Edoxaban 60mg | 414 | 82 | 227 | 93 | 12 | |
2.17 (1.96 - 2.38) | 1.94 (1.52 - 2.36) | 2.01 (1.75 - 2.27) | 2.86 (2.28 - 3.44) | 3.80 (1.65 - 5.95) | ||
Composite net clinical endpoints | ||||||
 Stroke, systemic embolic event, major bleeding or death | Warfarin | 1462 | 205 | 811 | 393 | 53 |
7.90 (7.50 - 8.31) | 4.97 (4.29 - 5.65) | 7.34 (6.84 - 7.85) | 12.86 (11.59 - 14.14) | 19.41 (14.19 - 24.64) | ||
Edoxaban 30mg | 1247 | 185 | 686 | 335 | 41 | |
6.58 (6.22 - 6.95) | 4.48 (3.83 - 5.13) | 6.06 (5.61 - 6.52) | 10.35 ( 9.24 - 11.46) | 15.71 (10.90 - 20.52) | ||
Edoxaban 60mg | 1321 | 231 | 685 | 361 | 44 | |
7.06 (6.68 - 7.44) | 5.56 (4.84 - 6.27) | 6.16 (5.70 - 6.62) | 11.51 (10.32 - 12.70) | 14.49 (10.21 - 18.77) | ||
 Disabling stroke, life-threatening bleeding, or death | Warfarin | 981 | 124 | 529 | 285 | 43 |
5.07 (4.75 - 5.39) | 2.91 (2.39 - 3.42) | 4.58 (4.19 - 4.98) | 8.79 (7.77 - 9.82) | 14.58 (10.22 - 18.93) | ||
Edoxaban 30mg | 836 | 124 | 448 | 236 | 28 | |
4.26 (3.97 - 4.55) | 2.93 (2.42 - 3.45) | 3.83 (3.47 - 4.18) | 6.95 (6.06 - 7.83) | 9.69 ( 6.10 - 13.28) | ||
Edoxaban 60mg | 882 | 139 | 454 | 259 | 30 | |
4.52 (4.22 - 4.81) | 3.21 (2.68 - 3.74) | 3.94 (3.58 - 4.30) | 7.76 (6.81 - 8.70) | 9.08 ( 5.83 - 12.33) | ||
 Stroke, systemic embolic event, life-threatening bleeding, or death | Warfarin | 1109 | 145 | 603 | 315 | 46 |
5.80 (5.45 - 6.14) | 3.43 (2.87 - 3.98) | 5.28 (4.86 - 5.70) | 9.88 ( 8.79 - 10.98) | 15.91 (11.31 - 20.51) | ||
Edoxaban 30mg | 999 | 148 | 542 | 280 | 29 | |
5.16 (4.84 - 5.48) | 3.53 (2.96 - 4.10) | 4.69 (4.30 - 5.09) | 8.42 (7.43 - 9.40) | 10.09 ( 6.42 - 13.77) | ||
Edoxaban 60mg | 990 | 168 | 501 | 287 | 34 | |
5.12 (4.80 - 5.43) | 3.92 (3.33 - 4.52) | 4.38 (3.99 - 4.76) | 8.70 (7.70 - 9.71) | 10.51 ( 6.98 - 14.04) | ||
 Death | Warfarin | 837 | 100 | 447 | 252 | 38 |
4.27 (3.98 – 4.56) | 2.32 (1.86 – 2.77) | 3.82 (3.47 – 4.18) | 7.62 (6.68 – 8.56) | 12.54 (8.56 – 16.53) | ||
Edoxaban 30mg | 736 | 107 | 387 | 217 | 25 | |
3.79 (3.52 – 4.06) | 2.51 (2.03 – 2.99) | 3.37 (3.04 – 3.71) | 6.34 (5.50 – 7.18) | 8.46 (5.14 – 11.77) | ||
Edoxaban 60mg | 772 | 121 | 391 | 231 | 29 | |
3.92 (3.64 – 4.19) | 2.77 (2.28 – 3.27) | 3.38 (3.05 – 3.72) | 6.81 (5.93 – 7.68) | 8.71 (5.54 – 11.89) | ||