Table 2b. Prevalence of Endocrine/Reproductive Late Effects in At-Risk Populations Following Exposure-Based Screening.

				Diagnosis before SJLIFE			Diagnosis related to SJLIFE			Diagnosis after SJLIFE			Overall Prevalence
Potential Late Effect	Screening test	Exposure Status	Number at riska	N	(%)	95% CI	N	(%)	95% CI	N	(%)	95% CI	N	(%)	95% CI
Endocrine/ Reproductive
Hypothalamic- pituitary axis (HPA) disorders (one or more)	Screening for HPA deficiencies: Growth & pubertal progress, Menstrual history, Insulin growth factor-1 (IGF-1), 8 am serum cortisol, Luteinizing hormone (LH), Follicle stimulating hormone (FSH), Estradiol or AM testosterone, Thyroid stimulating hormone (TSH), Free T4	Radiation to hypothalamus- pituitary (dose >=18 Gy)	685	355	(51.8)	[48.0-55.6]	57	(8.3)	[6.4-10.6]	6	(0.9)	[0.3-1.9]	418	(61.0)	[57.3-64.7]
Diabetes mellitus	Fasting serum glucose	Radiation to hypothalamus- pituitary	714	35	(4.9)	[3.4-6.8]	13	(1.8)	[1.0-3.1]	8	(1.1)	[0.5-2.2]	56f	(7.8)	[6.0-10.1]
Primary hypothyroidismb	TSH	Radiation to neck	910	117	(12.9)	[10.8-15.2]	7	(0.8)	[0.3-1.6]	1	(0.1)	[0.0-0.6]	125g	(13.8)	[11.6-16.1]
Primary ovarian failure	Menstrual history, FSH, Estradiol	Alkylating agents Radiation to female reproductive system	553	44	(8.0)	[5.8-10.5]	20	(3.6)	[2.2-5.5]	1	(0.2)	[0.0-1.0]	65h	(11.8)	[9.2-14.7]
Male germ cell dysfunctiond,e	Semen sample analysis	Alkylating agents Radiation to male reproductive system	328	9	(2.7)	[1.3-5.1]	209	(63.7)	[58.3-68.9]	0	(0.0)		218i	(66.4)	[61.1-71.6]
Leydig cell failured	Morning testosterone, LH	Alkylating agents Radiation to male reproductive system	574	25	(4.4)	[2.8-6.4]	37	(6.4)	[4.6-8.8]	4	(0.7)	[0.2-1.8]	66j	(11.5)	[9.0-14.4]
Any endocrine condition	As indicated above	As indicated above	1423	531	(37.3)	[34.8-39.9]	332	(23.3)	[21.2-25.6]	20	(1.4)	[0.9-2.2]	883	(62.0)	[59.5-64.6]

^aAt risk by treatment exposure as defined in the COG Guidelines, see supplemental Table 1 for detailed exposures and potential late effects evaluated by risk-based screening.

^bResults presented for evaluation of central and primary hypothyroidism and thyroid nodules exclude 39 patients with prior thyroidectomy.

^cResults presented for evaluation of hypogonadotropic hypogonadism and primary ovarian failure exclude 50 women with bilateral oophorectomy.

^dResults presented for evaluation of Leydig cell failure exclude 1 man with bilateral orchiectomy.

^eResults presented for evaluation of germ cell dysfunction exclude 246 at risk patients who declined semen analysis due to history of established fertility (81), infertility (43), inability to provide a sample (18) or personal reasons (107).

^f32.0% were CTCAE v.4 Grade 3-4

^gNone were CTCAE v.4 Grade 3-4

^hNone were CTCAE v.4 Grade 3-4

ⁱ97.7% were CTCAE v.4 Grade 3-4

^jNone were CTCAE v.4 Grade 3-4

CTCAE v.4 percentages includes only those who fulfill criteria for “at risk” as defined by COG Guidelines.