Table 1.

Patient characteristics of the pilot and validation study cohort

	Stage I-III patients non-irradiated arm TME trial (n = 685)		Pilot study		p value	Stage III patients non-irradiated arm TME trial (n = 281)		Validation study		p value
			(n = 49)					(n = 88)
	N	(%)	n	(%)		N	(%)	n	(%)
Gender
Male	432	63.1	35	71.4		181	64.4	62	70.5
Female	253	36.9	14	28.6	0.24	100	35.6	26	29.5	0.30
Age at randomization
Mean	64.3		66.0			63.37		62.59
Standard error	0.43		1.58		0.31	0.67		1.30		0.58
TNM stage
I	209	30.5	14	28.6
II	195	28.5	25	51.0
III	281	41.0	10	20.4	0.13	281	100	88	100	n.a.
Tumor location
Rectum	607	88.6	41	83.3		246	89.5	84	95.4
Anal region	48	12.4	8	16.7	0.45	21	10.5	4	4.5	0.06
Circumferential margin
Negative	555	81.0	36	73.5		187	66.5	67	76.1
Positive	129	19.0	13	26.5	0.34	93	33.5	21	23.9	0.10

Patient characteristics are shown for both the pilot and validation study groups. The pilot study included stage I–III rectal cancer patients (n = 49), the validation study stage III patients only (n = 88). Variables listed are standard clinicopathological factors used in multivariate analyses, i.e. gender, age at randomization, TNM stage, tumor location, and circumferential margin involvement. p-values representing the difference between the TME trial patients and the pilot or validation study cohort, respectively, were calculated using a Student’s t test