Observational Study
Copyright ©The Author(s) 2019.
World J Gastroenterol. Aug 7, 2019; 25(29): 4007-4018
Published online Aug 7, 2019. doi: 10.3748/wjg.v25.i29.4007
Table 2 Primary endpoint: dermatological toxicities (primary analysis set, n = 229)
Day 15 (n = 214)Month 1 (n = 208)Month 2 (n = 186)Month 3 (n = 153)Month 4 (n = 122)Month 5 (n = 93)Month 6 (n = 87)
At least one dermatological toxicity, n (%)127 (59.3)141 (67.8)139 (74.7)107 (69.9)76 (63.3)52 (57.1)40 (46.5)
Dermatological toxicities
Rash/acneiform rash, n (%)111 (51.9)123 (59.1)110 (59.1)85 (55.6)56 (45.9)41 (44.1)34 (39.1)
Grade 1-2101 (47.2)115 (55.3)99 (53.2)82 (53.6)51 (41.8)39 (41.9)33 (37.9)
Grade 3-410 (4.7)7 (3.4)8 (4.3)2 (1.1)4 (3.2)1 (1.1)1 (1.1)
Grade missing0131110
Skin cracks, n (%)5 (2.3)17 (8.2)35 (18.8)34 (22.2)23 (18.9)20 (21.5)17 (19.5)
Grade 1-24 (1.9)16 (7.7)32 (17.2)33 (21.6)22 (18.0)19 (20.4)17 (19.8)
Grade 3-41 (0.5)1 (0.5)3 (1.6)1 (0.6)1 (0.8)00
Grade missing0000010
Paronychia/Perionyxis, n (%)6 (2.8)11 (5.3)22 (11.8)15 (9.8)12 (9.8)9 (9.7)5 (5.7)
Grade 1-26 (2.8)10 (4.8)21 (11.3)15 (9.8)12 (9.8)8 (8.6)5 (5.7)
Grade 3-401 (0.5)1 (0.5)001 (1.1)0
Xerosis, n (%)27 (12.6)36 (17.3)53 (28.5)44 (28.8)22 (18.0)15 (16.1)11 (12.6)
Grade 1-227 (12.6)34 (16.3)51 (27.4)43 (28.1)21 (17.2)15 (16.1)11 (12.6)
Grade 3-402 (1.0)2 (1.1)01 (0.8)00
Grade missing0001000
Mucositis, n (%)12 (5.6)15 (7.2)19 (10.2)8 (5.2)3 (2.5)3 (3.2)2 (2.3)
Grade 1-212 (5.6)15 (7.2)18 (9.7)8 (5.2)3 (2.5)3 (3.2)2 (2.3)
Grade 3-4001 (0.5)0000
Hypertrichosis, n (%)1 (0.5)4 (1.9)5 (2.7)7 (4.6)7 (5.7)2 (2.2)2 (2.3)
Grade 1-21 (0.5)4 (1.9)5 (2.7)7 (4.6)7 (5.7)2 (2.2)2 (2.3)
Other, n (%)5 (2.3)5 (2.4)4 (2.2)4 (2.6)3 (2.5)01 (1.1)
Grade 1-25 (2.3)5 (2.4)4 (2.2)4 (2.6)3 (2.5)01 (1.1)