TABLE 1.
Demographics and Other Baseline Characteristics
| Demographic Characteristic | DB-020 12% Right Ear (n = 7) |
DB-020 12% Left Ear (n = 4) |
DB-020 25% Right Ear (n = 5) |
DB-020 25% Left Ear (n = 6) |
Overall (N = 22) |
|---|---|---|---|---|---|
| Age at consent, years | |||||
| Mean (SD) | 56.7 (12.76) | 56.0 (6.78) | 53.4 (6.23) | 54.0 (12.95) | 55.1 (10.12) |
| Median | 62.0 | 53.5 | 54.0 | 53.0 | 54.0 |
| Min, max | 37, 71 | 51, 66 | 46, 62 | 35, 69 | 35, 71 |
| Sex, No. (%) | |||||
| Male | 5 (71.4) | 4 (100) | 5 (100) | 5 (83.3) | 19 (86.4) |
| Female | 2 (28.6) | 0 | 0 | 1 (16.7) | 3 (13.6) |
| Race, No. (%) | |||||
| White | 7 (100) | 4 (100) | 5 (100) | 6 (100) | 22 (100) |
| Ethnicity, No. (%) | |||||
| Not Hispanic or Latino | 6 (85.7) | 3 (75.0) | 5 (100) | 5 (83.3) | 19 (86.4) |
| Unknown | 1 (14.3) | 1 (25.0) | 0 | 1 (16.7) | 3 (13.6) |
| ECOG performance status, No. (%) | |||||
| 0 | 7 (100) | 4 (100) | 5 (100) | 5 (83.3) | 21 (95.5) |
| 1 | 0 | 0 | 0 | 1 (16.7) | 1 (4.5) |
| Neoplasms benign, malignant, and unspecified, No. (%) | 6 (85.7)a | 4 (100) | 5 (100) | 6 (100) | 21 (95.5) |
| Tonsil cancer | 3 (42.9) | 2 (50.0) | 4 (80.0) | 3 (50.0) | 12 (54.5) |
| Squamous cell carcinoma of the tongue | 1 (14.3) | 1 (25.0) | 1 (20.0) | 1 (16.7) | 4 (18.2) |
| Oropharyngeal squamous cell carcinoma | 0 | 1 (25.0) | 0 | 1 (16.7) | 2 (9.1) |
| Squamous cell carcinoma | 1 (14.3) | 0 | 0 | 1 (16.7) | 2 (9.1) |
| Basal cell carcinoma | 0 | 0 | 0 | 1 (16.7) | 1 (4.5) |
| Lung neoplasm malignant | 1 (14.3) | 0 | 0 | 0 | 1 (4.5) |
| Malignant melanoma | 0 | 0 | 0 | 1 (16.7) | 1 (4.5) |
| Oral cavity cancer metastatic | 0 | 0 | 0 | 1 (16.7) | 1 (4.5) |
| Oropharyngeal cancer | 1 (14.3) | 0 | 0 | 0 | 1 (4.5) |
NOTE. Percentages are calculated as n/N*100.
Abbreviations: ECOG, Eastern Cooperative Oncology Group; ITT, intention-to-treat; SD, standard deviation.
a
One patient without a medical history term for neoplasm had a tonsillectomy shortly before enrollment.