. Author manuscript; available in PMC: 2014 Aug 14.

Published in final edited form as: Clin Cancer Res. 2013 May 15;19(10):2646–2656. doi: 10.1158/1078-0432.CCR-12-2939

Table 3.

Results of phase 2 interim analysis in SWOG phase 3 trials

			1	2	3	4	5	6	7	8	9

Study	Final	Power:	85%	85%	85%	90%	90%	90%	95%	95%	95%
	Result	Type I error:	10%	15%	20%	10%	15%	20%	10%	15%	20%
S8797	Positive	(accrual goal : 264, actual size: 268)
		Events	109	87	71	133	109	91	173	145	125
		N	262	262	262	262	262	262	262	262	262
		Accrual (%)	99%	99%	99%	99%	99%	99%	99%	99%	99%
		Phase II stop	No	No	No	No	No	No	No	No	No

S9008	Positive	(accrual goal : 600, actual size: 606)
		Events	97	78	64	119	97	82	155	130	112
		N	263	221	202	316	263	227	366	324	302
		Accrual (%)	44%	37%	34%	53%	44%	38%	61%	54%	50%
		Phase II stop	No	No	No	No	No	No	No	No	No

S9308	Positive	(accrual goal : 440, actual size: 432)
		Events	45	36	30	55	45	38	72	61	52
		N	119	110	98	138	119	110	152	143	127
		Accrual (%)	27%	25%	22%	31%	27%	25%	35%	33%	29%
		Phase II stop	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes

S9313	Negative	(accrual goal : 3240, actual size: 3176)
		Events	50	40	33	61	50	42	79	67	57
		N	1796	1598	1455	1957	1796	1618	2180	2050	1860
		Accrual (%)	55%	49%	45%	60%	55%	50%	67%	63%	57%
		Phase II stop	No	No	No	No	No	No	No	No	No

S9321	Negative	(accrual goal : 500, actual size: 575)
		Events	70	56	46	86	70	59	112	94	81
		N	205	174	166	234	205	184	298	253	227
		Accrual (%)	41%	35%	33%	47%	41%	37%	60%	51%	45%
		Phase II stop	Yes	No	Yes	Yes	Yes	Yes	Yes	No	Yes

S9415	Negative	(accrual goal : 1600, actual size: 1135)
		Events	207	166	136	253	207	174	330	277	238
		N	844	763	704	965	844	787	1004	1004	919
		Accrual (%)	53%	48%	44%	60%	53%	49%	63%	63%	57%
		Phase II stop	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes

S9420	Negative	(accrual goal : 700, actual size: 730)
		Events	59	47	39	72	59	49	94	79	68
		N	135	114	105	148	135	122	186	161	141
		Accrual (%)	19%	16%	15%	21%	19%	17%	27%	23%	20%
		Phase II stop	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes

S9438	Negative	(accrual goal : 206, actual size: 204)
		Events	88	70	58	107	88	74	140	118	101
		N	194	174	155	194	194	183	194	194	194
		Accrual (%)	94%	84%	75%	94%	94%	89%	94%	94%	94%
		Phase II stop	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes

S9509	Negative	(accrual goal : 440, actual size: 432)
		Events	45	36	29	55	45	38	71	60	51
		N	129	118	110	147	129	119	164	152	140
		Accrual (%)	29%	27%	25%	33%	29%	27%	37%	35%	32%
		Phase II stop	Yes	No	No	Yes	Yes	No	Yes	Yes	No

S9916	Positive	(accrual goal : 744, actual size: 770)
		Events	26	21	17	32	26	22	41	35	30
		N	100	92	87	117	100	93	128	122	114
		Accrual (%)	13%	12%	12%	16%	13%	13%	17%	16%	15%
		Phase II stop	No	No	No	No	No	No	No	No	No

S0001	Negative	(accrual goal : 400, actual size: 183)
		Events	47	38	31	58	47	40	76	64	55
		N	65	63	54	79	65	63	108	94	73
		Accrual (%)	16%	16%	14%	20%	16%	16%	27%	24%	18%
		Phase II stop	Yes	No	No	Yes	Yes	No	Yes	Yes	Yes

S0003	Negative	(accrual goal : 550, actual size: 397)
		Events	69	55	45	84	69	58	109	92	79
		N	148	121	105	160	148	122	191	169	157
		Accrual (%)	27%	22%	19%	29%	27%	22%	35%	31%	29%
		Phase II stop	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes

S0023	Negative	(accrual goal : 672, actual size: 284)
		Events	45	36	30	55	45	38	72	61	52
		N	109	92	86	136	109	93	160	140	130
		Accrual (%)	16%	14%	13%	20%	16%	14%	24%	21%	19%
		Phase II stop	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes

S0124	Negative	(accrual goal : 680, actual size: 671)
		Events	84	67	55	102	84	70	133	112	96
		N	148	130	123	168	148	136	218	180	165
		Accrual (%)	22%	19%	18%	25%	22%	20%	32%	26%	24%
		Phase II stop	No	No	No	No	No	No	No	No	No

S0205	Negative	(accrual goal : 704, actual size: 766)
		Events	84	67	55	102	84	70	133	112	96
		N	173	157	146	200	173	161	239	211	191
		Accrual (%)	25%	22%	21%	28%	25%	23%	34%	30%	27%
		Phase II stop	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes