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Table 2 Treatment compliance

From: 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

Number of doses Placebo
N = 31
Rebamipide 2%
N = 31
Rebamipide 4%
N = 32
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
  1. Number of doses, total doses of cisplatin, and total radiation dose are expressed as mean ± standard deviation
  2. 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
  3. bSwallowing rate (%) = Total number of IMP swallowed ÷ [(end date of IMP administration - start date of IMP administration +1) × 6] × 100