Table 1.
Demographic and pathologic data with comparison between Vaccine vs. Placebo, and in the 3-arm analysis (TLPLDC vs TLPLDC + G vs placebo)
| Category | Intention to treat analysis | Three-arm analysis | ||||||
|---|---|---|---|---|---|---|---|---|
| Vaccine (%) | Placebo (%) | p-value | TLPLDC (%) | TLPLDC + G (%) | Placebo (%) | p-value | ||
| Age | ||||||||
| Median | 65.5 | 58.7 | 0.037 | 69.5 | 61.7 | 58.7 | 0.042 | |
| IQR | 55.6 ˗ 73.0 | 49.5˗67.8 | 57.2˗75.2 | 55.5˗70.1 | 49.5˗67.8 | |||
| Race | ||||||||
| Asian | 0 (0) | 1 (2.4) | 0.320 | 0 (0) | 0 (0) | 1 (2.4) | 0.583 | |
| Black | 0 (0) | 1 (2.4) | 0 (0) | 0 (0) | 1 (2.4) | |||
| Hispanic | 3 (2.9) | 1 (2.4) | 1 (2.1) | 2 (3.5) | 1 (2.4) | |||
| Native American | 1 (1.0) | 0 (0) | 0 (0) | 1 (1.8) | 0 (0) | |||
| Unknown | 1 (1.0) | 0 (0) | 0 (0) | 1 (1.8) | 0 (0) | |||
| White | 98 (95.1) | 38 (92.7) | 46 (97.9) | 52 (92.9) | 38 (92.7) | |||
| Ulceration | ||||||||
| Present | 17 (16.5) | 12 (29.3) | 0.316 | 7 (14.9) | 10 (17.9) | 12 (29.3) | 0.316 | |
| Absent | 22 (21.4) | 7 (17.1) | 11 (23.4) | 11 (19.6) | 7 (17.1) | |||
| Not available | 64 (62.1) | 22 (53.7) | 29 (61.7) | 35 (62.5) | 22 (53.6) | |||
| TILS | ||||||||
| Brisk | 3 (2.9) | 2 (4.9) | 0.462 | 1 (2.1) | 2 (3.6) | 2 (4.9) | 0.247 | |
| Mild | 2 (1.9) | 0 (0) | 0 (0) | 2 (3.6) | 0 (0) | |||
| Non-Brisk | 14 (13.6) | 10 (24.4) | 9 (19.1) | 5 (8.9) | 10 (24.4) | |||
| Absent | 8 (7.8) | 1 (2.4) | 5 (10.6) | 3 (5.4) | 1 (2.4) | |||
| Not available | 76 (73.8) | 28 (68.3) | 32 (68.1) | 44 (78.6) | 28 (68.3) | |||
| Biopsy Margins | ||||||||
| Positive | 26 (25.2) | 13 (31.7) | 0.756 | 16 (34.0) | 10 (17.9) | 13 (31.7) | 0.330 | |
| Negative | 46 (44.7) | 19 (46.3) | 18 (38.3) | 28 (50.0) | 19 (46.3) | |||
| Not available | 31 (30.1) | 9 (22.0) | 13 (27.7) | 18 (32.1) | 9 (22.0) | |||
| BRAF Mutation | ||||||||
| Yes | 18 (17.5) | 6 (14.6) | 0.648 | 10 (21.3) | 8 (14.3) | 6 (14.6) | 0.768 | |
| No | 31 (30.1) | 10 (24.5) | 13 (27.7) | 18 (32.1) | 10 (24.4) | |||
| Not available | 54 (52.4) | 25 (61.0) | 24 (51.1) | 30 (53.6) | 25 (61.0) | |||