Table 3.

Adverse Events Associated With Treatment

Adverse Event	8-Week AS → Radiotherapy + AS (early, n = 747; late, n = 742)						28-Week AS → Radiotherapy + AS (early, n = 735; late, n = 724)						P*
	Grade 1		Grade 2		Grade 3		Grade 1		Grade 2		Grade 3
	No. of Patients	%	No. of Patients	%	No. of Patients	%	No. of Patients	%	No. of Patients	%	No. of Patients	%
Early
Constitutional	139	19	31	4	1	< 1	179	24	54	7	1	< 1	.01
Endocrine	263	35	197	26	4	< 1	267	36	323	44	12	2	< .001
GI	219	29	119	16	15	2	238	32	125	17	19	3	.43
Hepatic	92	12	32	4	16	2	122	17	24	3	6	1	.05
Sexual	12	2	12	2	60	8	21	3	38	5	122	17	< .001
Urinary	269	36	168	22	33	4	270	37	190	26	37	5	.10
Any	230	31	311	42	120	16	143	20	366	50	189	26	< .001
Late
Bladder	165	22	85	11	28	4	151	21	97	13	15	2	.89
GU, other	110	15	65	9	21	3	128	18	52	7	22	3	.45
Intestinal	151	20	40	5	7	< 1	155	21	37	5	7	1	1.00
GI, other	108	15	23	3	9	1	114	16	36	5	3	< 1	.40
Other	100	13	26	4	20	3	106	15	31	4	23	3	.54
Any	252	34	152	21	72	10	238	33	163	23	58	8	.82

NOTE. A patient may have more than one type of adverse event; five patients experienced a grade 4 (life-threatening) event. Grade 1 is mild; grade 2 is moderate; and grade 3 is severe.

Abbreviations: AS, androgen suppression; GU, genitourinary.

^*Fisher's exact test of between-group differences in grade ≥ 2 adverse events.