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. 2022 Jun 13;28:100943. doi: 10.1016/j.conctc.2022.100943

Table 5.

Dosing Decision Rules for the TITE-BOIN-ET Design.

Cumulative number of responses
Cumulative number of toxicities 0 1 2 3
0 E E if ESSEj >2.07
S if ESSE j ≤ 2.07
S S
1 E/S/D if ESSTj ≥2.87a
D if ESSTj<2.87
E/S/D if ESSEj >2.07 and ESSTj ≥2.87a
S if ESSEj ≤2.07 and ESSTj ≥2.87,
D if ESSTj<2.87
S if ESSTj ≥2.87
D if ESST j < 2.87
S if ESSTj ≥2.87
D if ESST j < 2.87
2 D D D D
3 D D D D

E = Escalate, D = De-escalate and S=Stay.

a

The rules used in the E/S/D cases in TITE-BOIN-ET to decide whether to escalate, de-escalate or stay at the same dose are the same as those used in BOIN-ET for the E/S/D case to decide whether to escalate, de-escalate or stay at the same dose (see BOIN-ET section).