Table 2.
Phase 0 trial participant demographics, clinico-pathologic features, and adherence measurements for the NCT01465776 protocol.
| Patients, N | (%) | ||
|---|---|---|---|
| Sex, Race/Ethnicity | |||
| Male | 26 | 68% | |
| Female | 12 | 32% | |
| NHW | 37 | 97% | |
| NHB | 1 | 3% | |
| Age (years) | |||
| < 45 | 6 | 16% | |
| 45–60 | 16 | 42% | |
| > 60 | 16 | 42% | |
| Range | 37 – 79 | ||
| Average | 57.5 | ||
| Tumor Location | |||
| Gingival | 1 | 3% | |
| Floor of Mouth | 6 | 16% | |
| Mandibular | 2 | 5% | |
| Maxillary | 1 | 3% | |
| Retromolar | 3 | 8% | |
| Tongue | 24 | 65% | |
| Tumor Stage | |||
| 1 | 10 | 27% | |
| 2 | 9 | 24% | |
| 3 | 6 | 16% | |
| 4 | 12 | 32% | |
| HPV Status | |||
| − | 24 | 83% | |
| + | 5 | 17% | |
| Smoking Status | |||
| Never | 12 | 32% | |
| Former | 9 | 24% | |
| Current | 17 | 45% | |
| Alcohol Use | |||
| Never | 10 | 28% | |
| Former | 8 | 22% | |
| Current | 18 | 50% | |
| BMI | |||
| < 18.50 | underweight | 1 | 3% |
| 18.50 – 24.99 | normal | 8 | 21% |
| ≥ 25.00 | overweight | 29 | 76% |
| ≥ 30.00 | obese | 19 | 50% |
| Range | 16 – 48 | ||
| Average | 29.5 | ||
| Duration (Days) | |||
| < 7 | 4 | 13% | |
| 7–21 | 23 | 77% | |
| > 21 | 3 | 10% | |
| Range | 5 – 34 | ||
| Average | 13.9 | ||
| Median | 12.5 | ||
| Dose (Troches) | |||
| < 166 | 18 | 60% | |
| 166 – 250 | 8 | 27% | |
| > 250 | 4 | 13% | |
| Range | 60 – 408 | ||
| Average | 165.5 | ||
| Median | 141.0 |