Table 1.

Dose-escalation and de-escalation boundaries for TITE-keyboard with a target DLT rate of 0.3 and cohort size of 3, up to 12 patients

Num. patients	Num. DLTs	Num. pending	Escalation patients	Stay DLTs	De-escalation pending
3	0	1				Y
3	0	2	Suspend accrual
3	1	0		Y
3	1	1–2
3		1			Y
3					Y&Eliminate
6	0	4	Y
6	1	1	Y
6	1	2–3
6	1	4–5
6	2	0		Y
6	2	1–4
6		3			Y
6	4	2			Y&Eliminate
9	0	7	Y
9	1	4	Y
9	1	5–6
9	1	7–8
9	2	0		Y
9	2	1–3
9	2	4–7
9	3	0		Y
9	3	1–6
9		5			Y
9	5	4			Y&Eliminate
12	0	10	Y
12	1	7	Y
12	1	8–9
12	1	10–11
12	2	3	Y
12	2	4–6
12	2	7–10
12	3	3		Y
12	3	4–9
12	4	0		Y
12	4	1–8
12	5,6	7			Y
12	7	5			Y&Eliminate

, which is the effective sample size. Dose escalation is not allowed if fewer than two patients at dose level have finished the assessment. “Y” means Yes. At each time for decision making, the observed data should be updated before using the table to determine the dose for the next patient.