TABLE V.

Dosing symptoms on active therapy

				Patch-site reactions												Non-patch-site symptoms
		Any reaction		Any patch-site reaction		Grade 2 patch-site reaction		Grade 3 patch-site reaction		Grade 4 patch-site reaction		Reaction extended past patch site		Non–patch-site reaction		Mild symptoms		Moderate symptoms		Severe symptoms		Symptoms >8 h		Treated
Dosing symptoms by dose
Treatment group	No. of doses	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%
PLB-VP250	16,592	12,878	77.6	12,875	77.6	2,887	17.4	8	0.0	0	0.0	3,281	19.77	17	0.1	17	0.1	0	0.00	0	0.00	11,515	69.4	2,145	12.9
VP100-VP250	18,509	13,382	72.3	13,379	72.3	2,694	14.6	9	0.0	1	0.0	952	5.14	22	0.1	21	0.1	1	0.01	0	0.00	10,835	58.5	4,852	26.2
VP250	21,707	16,047	73.9	16,044	73.9	4,500	20.7	12	0.1	0	0.0	2,597	11.96	35	0.2	35	0.2	0	0.00	0	0.00	14,738	67.9	3,904	18.0
Dosing symptoms by subject
Treatment group	No. of subjects	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%
PLB-VP250	20	20	100.0	20	100.0	16	80.0	4	20.0	0	0.0	17	85.00	6	30.0	6	30.0	0	0.00	0	0.00	18	90.0	17	85.0
VP100-VP250	24	24	100.0	24	100.0	22	91.7	5	20.8	1	4.2	22	91.67	8	33.3	7	29.2	1	4.17	0	0.00	22	91.7	23	95.8
VP250	25	25	100.0	25	100.0	25	100.0	7	28.0	0	0.0	25	100.00	7	28.0	7	28.0	0	0.00	0	0.00	25	100.0	25	100.0

Dosing symptoms by percent of doses per subject
Treatment group	No. of doses	Median (IQR)	Median (IQR)	Median (IQR)	Median (IQR)	Median (IQR)	Median (IQR)	Median (IQR)	Median (IQR)	Median (IQR)	Median (IQR)	Median (IQR)	Median (IQR)
PLB-VP250	865.5 (827.5–896)	92.6 (70.2–97.4)	92.4 (70.2–97.4)	4.6 (0.1–27.1)	0 (0–0)	0 (0–0)	2.1 (0.5–22.4)	0 (0–0.2)	0 (0–0.2)	0 (0–0)	0 (0–0)	81.1 (51.1–92.9)	1.4 (0.1–18.9)
VP100-VP250	892.5 (828–900.5)	89.4 (57.8–97.4)	89.4 (57.8–97.4)	4.3 (1.1–15.2)	0 (0–0)	0 (0–0)	1.7 (0.8–3.7)	0 (0–0.1)	0 (0–0.1)	0 (0–0)	0 (0–0)	53.3 (19.3–88.4)	10 (0.3–40.9)
VP250	893 (860–907)	95.3 (63.2–98.3)	95.3 (63.2–98.3)	3.8 (0.8–27.6)	0 (0–0.1)	0 (0–0)	3.9 (0.7–23.8)	0 (0–0.1)	0 (0–0.1)	0 (0–0)	0 (0–0)	90.1 (21.5–97.3)	9.2 (1.9–18.6)