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. 2016 Apr 15;5(4):222–232. doi: 10.1002/psp4.12077

Table 4.

Final risk factor and exposure‐response models for safety endpoints

  Final warfarin risk factor model a Final edoxaban exposure‐response model b
Parameter Estimate [90% CI] c HR Estimate [90% CI] c HR
Clinically relevant bleeding
 λ [day−1] 3.24·10−5 [1.83·10−5, 4.65·10−5] ‐ 3.05·10−5 [1.62·10−5, 4.48·10−5] ‐
 γ 0.553 [0.511, 0.595] ‐ 0.629 [0.577, 0.681] ‐
  β AGE75 0.320 [0.110, 0.531] 1.38 0.305 [0.076, 0.534] 1.36
  β ASA 0.458 [0.244, 0.672] 1.58 0.762 [0.547, 0.978] 2.14
  β CAN 0.474 [0.216, 0.732] 1.61 0.110 [−0.222, 0.442] 1.12
  β PUL 0.465 [0.278, 0.653] 1.59 0.168 [−0.0557, 0.392] 1.18
  β RCAN 0.612 [0.206, 1.02] 1.84 0.794 [0.309, 1.28] 2.21
  β SUR 0.317 [0.123, 0.511] 1.37 0.395 [0.186, 0.604] 1.48
  β SEX 0.244 [0.0815, 0.407] 1.28 0.678 [0.497, 0.859] 1.97
All death
 λ [day−1] 8.605·10−5 [4.703·10−5, 1.251·10−4] ‐ 3.15·10−5 [−6.37·10−6, 1.27·10−5] ‐
 γ −0.01059 [−0.01500, −0.006177] ‐ 0.458 [0.327, 0.590] ‐
  βRCAN 1.619 [0.6194, 2.619] 5.048 1.49 [0.485, 2.49] 4.42
  βL,ER (Cmax) [(ng/mL)−1] ‐ ‐ −0.00865 [−0.0139, −0.00337] 0.991 d
MACE
 λ [day−1] 3.44·10−5 [2.22·10−5, 4.67·10−5] ‐ 4.16·10−6 [−2.435·10−6, 1.08·10−5] ‐
 γ 0.685 [0.531, 0.840] ‐
  βAGE75 0.9363 [0.327, 1.55] 2.551 1.25 [0.747, 1.75] 3.49
  βCAN 1.10 [0.484, 1.72] 3.016 ‐ ‐
  β SEX −0.673 [−1.25, −0.0973] 0.510 ‐ ‐

λ, scale factor of the exponential, Weibull, or Gompertz distribution; γ, shape factor of the Weibull or Gompertz distribution; β, coefficient describing risk factor; AGE75, age ≥75 at baseline; ASA, concomitant use of aspirin or antiplatelet agent; CAN, history of cancer; CI, confidence interval; ER, exposure response; HR, hazard ratio; PUL, history of pulmonary disease; RCAN, recent active cancer; SEX, female gender; SUR, recent surgery, trauma, or immobilization.

aBased on warfarin patients.

bBased on edoxaban patients.

cEstimates of risk factor effects parameterized as log hazard ratio, and CI obtained from the observed Fisher information matrix.

dDecrease in the hazard ratio with every 1 ng/ml of Cmax of edoxaban.