Efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study

Table 2 Treatment compliance

Number of doses	Placebo N = 31	Rebamipide 2% N = 31	Rebamipide 4% N = 32
Number of doses	297 ± 168	278 ± 171	343 ± 135
Retention compliance,^a n (%)
≥ 80%	18 (58.1)	18 (58.1)	25 (78.1)
≥ 50% to <80%	6 (19.4)	7 (22.6)	6 (18.8)
< 50%	7 (22.6)	6 (19.4)	1 (3.1)
Swallowing rate,^b n (%)
≥ 80%	9 (29.0)	13 (41.9)	14 (43.8)
≥ 50% to <80%	6 (19.4)	8 (25.8)	6 (18.8)
< 50%	16 (51.6)	10 (32.3)	12 (37.5)
Total doses of cisplatin (mg/m²)	213 ± 73	192 ± 66	233 ± 61
The total radiation dose (Gy)	58 ± 20	55 ± 22	63 ± 13
Frequency of interruption of radiotherapy
0 times	28 (90.3)	29 (93.5)	30 (93.8)
1 times	3 (9.7)	2 (6.5)	1 (3.1)
2 times	0	0	0
3 times	0	0	0

Number of doses, total doses of cisplatin, and total radiation dose are expressed as mean ± standard deviation
^aRetention means keeping the investigational medicinal product for 30 s or more in the mouth. Retention compliance (%) = Total number of investigational medicinal product (IMP) retention ÷ [(end date of IMP administration - start date of IMP administration +1) × 6] × 100
^bSwallowing rate (%) = Total number of IMP swallowed ÷ [(end date of IMP administration - start date of IMP administration +1) × 6] × 100

ISSN: 1471-2407