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.
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).