A comparison of a new multinomial stopping rule with stopping rules of fleming and gehan in single arm phase II cancer clinical trials

Table 3 Thresholds by DESR to compare with rules of Gehan (r _alt = 0.2, r _nu _l = 0.05, epd _alt = 0.3, epd _nul = 0.5, power = 0.8, alpha = 0.05)

Study Size		Stage 1 Drug Rejection		Stage 2 Drug Acceptance		Power	Alpha Error	EN_nul/PES_nul	EN_alt/PES_alt
n ₁	n ₂	n _1r	n _1p	n _1r+n _2r	n _1p+n _2p
14	1	≤1/14	≥6/14	≥2/17	≤5/17	0.811	0.075	14.1/0.91	14.8/0.17
14	3	≤1/14	≥6/14	≥3/17	≤7/17	0. 773	0.043	14.3/0.91	16.5/0.17
14	4	≤1/14	≥6/14	≥3/18	≤7/18	0.775	0.038	14.3/0.91	17.3/0.17
14	5	≤1/14	≥6/14	≥3/19	≤7/19	0.773	0.034	14.4/0.92	18.2/0.17
14	6	≤1/14	≥6/14	≥3/20	≤7/20	0.769	0.031	14.5/0.91	19.0/0.17
14	9	≤1/14	≥6/14	≥3/23	≤9/23	0.805	0.038	14.8/0.91	21.5/0.17
14	10	≤1/14	≥6/14	≥4/24	≤9/24	0.753	0.026	14.9/0.91	22.3/0.17
14	11	≤1/14	≥6/14	≥3/25	≤9/25	0.797	0.033	14.9/0.91	23.2/0.17
14	13	≤1/14	≥6/14	≥4/27	≤11/27	0.791	0.023	15.1/0.91	24.8/0.17
14	15	≤1/14	≥6/14	≥4/29	≤11/29	0.789	0.024	15.3/0.91	26.5/0.17
14	16	≤1/14	≥6/14	≥4/30	≤11/30	0.787	0.028	15.4/0.91	27.3/0.17
14	18	≤1/14	≥6/14	≥4/32	≤13/32	0.811	0.023	15.5/0.91	29.0/0.17
14	20	≤1/14	≥6/14	≥5/34	≤13/34	0.781	0.015	15.7/0.91	30.7/0.17
14	21	≤1/14	≥6/14	≥5/35	≤13/35	0.779	0.013	15.8/0.91	31.5/0.17
14	22	≤1/14	≥6/14	≥5/36	≤15/36	0.803	0.016	15.9/0.91	32.3/0.17
14	23	≤1/14	≥6/14	≥5/37	≤15/37	0.804	0.014	16.0/0.91	33.2/0.17

EN_nul = expected number of patients accrued if a drug meets the criteria of the null hypothesis
EN_alt = expected number of patients accrued if a drug meets the criteria of the alternate hypothesis
PES_nul = probability of stopping the trial after stage I if a drug meets the criteria of the null hypothesis
PES_alt = probability of stopping the trial after stage I if a drug meets the criteria of the alternate hypothesis

ISSN: 1471-2288