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. 2020 Jul 21;61(1):52–63. doi: 10.1002/jcph.1696

Table 4.

Parameter Estimates of Final Cox Models for Selected TEAEs

Parameter Estimate SE HR 95%CI of HR P
≥ Grade 3 TEAEs
Asian (vs non‐Asian) 0.4736 0.2338 1.606 1.016‐2.539 .0279
AUCTEAE (μg·day/mL) × 50 −0.2195 0.1169 0.803 0.639‐1.010 .0538
≥ Grade 1 bone pain
Asian (vs non‐Asian) −1.3755 0.3507 0.253 0.127‐0.503 .0002
Splenectomy, yes −0.6107 0.2366 0.543 0.342‐0.863 .0216
AUCTEAE (μg·day/mL) × 50 −0.2718 0.1158 0.762 0.607‐0.956 .0153

AUCTEAE, area under the concentration‐time curve at steady state during the dosing interval when the event occurred; CI, confidence interval; HR, hazard ratio; P, tail probability of the chi‐squared distribution (likelihood ratio test); SE, standard error; TEAE, treatment‐emergent adverse event.