Table 1.

Diarrhea and proctitis CTCAE v4 grading criterion.²⁰

Adverse event	Grade toxicity
	0	1	2	3	4	5
Diarrhea	No change	Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline	Increase of 4–6 stools per day over baseline; moderate increase in ostomy output compared to baseline	Increase of ≥7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL	Life-threatening consequences; urgent intervention indicated	Death
Proctitis	No change	Rectal discomfort, intervention not indicated	Symptoms (e.g., rectal discomfort, passing blood or mucus); medical intervention indicated; limiting instrumental ADL	Severe symptoms; fecal urgency or stool incontinence; limiting self care ADL	Life-threatening consequences; urgent intervention indicated	Death