Table 2.

Acute ≥ grade 3 toxicities and adverse events

	Standard planning, n = 30		Adaptive planning, n = 33		Overall, n = 63
	n	% (95% CI)	n	% (95% CI)	n	% (95% CI)
Toxicity
Non-GU∗	4	13.3% (3.8-30.7)	2	6.1% (0.7-20.2)	6	9.5% (3.6-19.6)
GI†	1	3.3 % (0.1-17.2)	1	3.0% (0.1-15.8)	2	3.2% (0.4-11.0)
GU‡	5	17.2 % (5.8-35.8)	3	9.1% (1.9-24.3)	8	12.9% (5.7-23.9)
Any	7	23.3% (9.9-42.3)	5	15.2% (5.1-31.9)	12	19.0% (10.2-30.9)
Adverse event
Non-GU	10	33.3% (17.3-52.8)	7	21.2% (9.0-38.9)	17	27.0% (16.6-39.7)
GI†	1	3.3% (0.1-17.2)	2	6.1% (0.7-20.2)	3	4.8% (1.0-13.3)
GU‡	8	27.6% (12.7-47.2)	3	9.1% (1.9-24.3)	11	17.7% (9.2-29.5)
Any	10	33.3% (17.3-52.8)	10	30.3% (15.6-48.7)	20	31.7% (20.6-44.7)

Abbreviation: GI = gastrointestinal; GU = genitourinary; SP = standard planning.

Adverse event refers to an event that was not present at baseline or was reported at a higher grade than at baseline, and toxicity refers to the subset of adverse events that were categorized as treatment related.

^∗This row shows the primary endpoint.

^†GI is a subset of non-GU.

^‡One SP patient with GU had data that was not assessable. The patient was counted in the denominator.