Table 3.

Number of patients with an adverse event by system organ class, term, and grade

System organ class	Acute						Late
	5 fractions (n = 119)			12 fractions (n = 121)			5 fractions (n = 119)			12 fractions (n = 121)
	Grade			Grade			Grade			Grade
	3	4	5	3	4	5	3	4	5	3	4	5
Gastrointestinal disorders	1	0	0	2	0	0	1	0	0	1	0	0
Colonic fistula	0	0	0	0	0	0	0	0	0	1	0	0
Diarrhea	1	0	0	0	0	0	0	0	0	0	0	0
Proctitis	0	0	0	2	0	0	1	0	0	1	0	0
Renal and urinary disorders	1	0	0	0	0	0	1	0	0	1	0	0
Cystitis noninfective	0	0	0	0	0	0	1	0	0	0	0	0
Renal and urinary disorders, other	0	0	0	0	0	0	1	0	0	0	0	0
Urinary incontinence	0	0	0	0	0	0	1	0	0	0	0	0
Urinary retention	1	0	0	0	0	0	0	0	0	1	0	0
Urinary tract obstruction	0	0	0	0	0	0	1	0	0	0	0	0

Includes adverse events for which relationship to protocol treatment is missing. Adverse events were graded with Common Terminology Criteria for Adverse Events version 4. Gastrointestinal/genitourinary grade 3+ treatment-related toxicity definitely, probably, or possibly related to protocol treatment.