Table 2.

Summary of the maximum score for each of the six individual LSRs post-baseline in phase III studies (safety population)

Maximum grade post-baseline	Face/scalp		Trunk/extremities
	Ingenol mebutate 0.015% (n = 274)	Vehicle (n = 271)	Ingenol mebutate 0.05% (n = 225)	Vehicle (n = 232)
Erythema, n (%)
0	1 (0.4)	105 (38.7)	5 (2.2)	112 (48.3)
1	25 (9.1)	127 (46.9)	31 (13.8)	102 (44.0)
2	56 (20.4)	33 (12.2)	94 (41.8)	16 (6.9)
3	125 (45.6)	6 (2.2)	61 (27.1)	2 (0.9)
4	66 (24.1)	0 (0.0)	34 (15.1)	0 (0.0)
Any grade >0	272 (99.3)	166 (61.3)	220 (97.8)	120 (51.7)
Flaking/scaling, n (%)
0	7 (2.6)	89 (32.8)	3 (1.3)	83 (35.8)
1	52 (19.0)	142 (52.4)	52 (23.1)	131 (56.5)
2	91 (33.2)	36 (13.3)	86 (38.2)	15 (6.5)
3	98 (35.8)	4 (1.5)	66 (29.3)	3 (1.3)
4	25 (9.1)	0 (0.0)	18 (8.0)	0 (0.0)
Any grade >0	266 (97.1)	182 (67.2)	222 (98.7)	149 (64.2)
Crusting, n (%)
0	44 (16.1)	219 (80.8)	50 (22.2)	188 (81.0)
1	85 (31.0)	47 (17.3)	105 (46.7)	38 (16.4)
2	64 (23.4)	5 (1.8)	39 (17.3)	4 (1.7)
3	64 (23.4)	0 (0.0)	23 (10.2)	2 (0.9)
4	16 (5.8)	0 (0.0)	8 (3.6)	0 (0.0)
Any grade >0	229 (83.6)	52 (19.2)	175 (77.8)	44 (19.0)
Swelling, n (%)
0	56 (20.4)	257 (94.8)	82 (36.4)	219 (94.4)
1	88 (32.1)	12 (4.4)	65 (28.9)	13 (5.6)
2	67 (24.5)	2 (0.7)	51 (22.7)	0 (0.0)
3	48 (17.5)	0 (0.0)	20 (8.9)	0 (0.0)
4	14 (5.1)	0 (0.0)	7 (3.1)	0 (0.0)
Any grade >0	217 (79.2)	14 (5.2)	143 (63.6)	13 (5.6)
Vesiculation/pustulation, n (%)
0	119 (43.4)	270 (99.6)	127 (56.4)	230 (99.1)
1	36 (13.1)	1 (0.4)	46 (20.4)	1 (0.4)
2	53 (19.3)	0 (0.0)	30 (13.3)	1 (0.4)
3	50 (18.2)	0 (0.0)	19 (8.4)	0 (0.0)
4	15 (5.5)	0 (0.0)	3 (1.3)	0 (0.0)
Any grade >0	154 (56.2)	1 (0.4)	98 (43.6)	2 (0.9)
Erosion/ulceration, n (%)
0	186 (67.9)	267 (98.5)	167 (74.2)	226 (97.4)
1	55 (20.1)	4 (1.5)	37 (16.4)	6 (2.6)
2	26 (9.5)	0 (0.0)	15 (6.7)	0 (0.0)
3	5 (1.8)	0 (0.0)	4 (1.8)	0 (0.0)
4	1 (0.4)	0 (0.0)	2 (0.9)	0 (0.0)
Any grade >0	87 (31.8)	4 (1.5)	58 (25.8)	6 (2.6)

LSR Local skin response