Covariate | Treatment arm, no. (%) | Pa | |||
---|---|---|---|---|---|
CT alone, n = 16 | CT+MB 0.025%, n = 15 | CT+MB 0.05%, n = 14 | CT+MB 0.1%, n = 15 | ||
Sex | 0.9847 | ||||
Male | 10 (63) | 10 (67) | 9 (64) | 9 (60) | |
Female | 6 (38) | 5 (33) | 5 (36) | 6 (40) | |
Age (in years), median (range) | 48 (26–65) | 45 (26–76) | 43 (21–70) | 32 (19–75) | 0.5413 |
Race | 0.8039 | ||||
White | 15 (94) | 11 (73) | 11 (79) | 11 (73) | |
Black | 1 (6) | 1 (7) | 0 (0) | 1 (7) | |
Asian | 0 (0) | 1 (7) | 1 (7) | 1 (7) | |
Other | 0 (0) | 2 (13) | 2 (14) | 2 (13) | |
Therapy | 0.2740 | ||||
CAR-T | 0 (0) | 0 (0) | 1 (7) | 1 (7) | |
Chemotherapy | 3 (19) | 2 (13) | 6 (43) | 4 (27) | |
SCT | 13 (81) | 13 (87) | 7 (50) | 10 (67) | |
Mucositis severity | 0.1090 | ||||
Grade 2 | 1 (6) | 0 (0) | 1 (7) | 4 (27) | |
Grade 3 | 15 (94) | 15 (100) | 13 (93) | 11 (73) | |
Mucositis location | 0.8758 | ||||
Oral mucosa | 8 (50) | 9 (60) | 8 (57) | 7 (47) | |
Esophageal | 8 (50) | 6 (40) | 6 (43) | 8 (53) | |
Baseline pain NRS score | 0.9453 | ||||
0–5 | 4 (25) | 2 (13) | 3 (21) | 3 (20) | |
6–10 | 12 (75) | 13 (87) | 11 (79) | 12 (80) | |
Baseline OFB score | 0.6811 | ||||
0–3 | 2 (13) | 2 (13) | 3 (21) | 1 (7) | |
4–6 | 14 (88) | 13 (87) | 11 (79) | 14 (93) | |
Pain duration (in days), median (range) | 5.5 (3–8) | 8 (2–90) | 6 (1–43) | 5 (2–30) | 0.1046 |
OFB scoreb | |||||
Baseline, median (range) | 5 (2–6) | 5 (2–6) | 4.5 (2–6) | 5 (2–6) | 0.8428 |
Day 1, median (range) | 4.5 (1–6) | 3 (0–5) | 2 (0–5) | 2 (0–6) | 0.0210 |
Day 2, median (range) | 4 (0–6) | 2 (0–5) | 1 (0–5) | 2 (0–5) | 0.0008 |
Reduction at day 2, mean ± SD | 0.81 ± 1.11 | 2.47 ± 1.55 | 2.79 ± 1.72 | 2.87 ± 1.60 | 0.0008 |
MEDD baseline, median (range) | 117.5 (16.4–825) | 115 (12.5–535) | 107 (15–648) | 120 (5–3153) | 0.9182 |
Pain NRS scorec | |||||
Baseline, median (range) | 6.5 (4–10) | 8 (3–10) | 7.5 (4–10) | 8 (3–10) | 0.1884 |
Day 1, median (range) | 6 (2–9) | 4 (0–8) | 3 (0–7) | 3 (0–8) | 0.0052 |
Day 2, median (range) | 5.5 (0–8) | 3 (0–8) | 2 (0–7) | 2 (0–8) | 0.0316 |
Reduction at day 2, mean ± SD | 1.69 ± 3.09 | 5.2 ± 2.81 | 4.54 ± 2.93 | 5.15 ± 2.64 | 0.0034 |