TABLE 5.
Characteristics of screening and enrichment populations of the VALGENT-3 panela
| Characteristic | Value for: |
||
|---|---|---|---|
| Screening population | Enrichment population | Total | |
| Mean (range) age (yr) | 39 (21–64) | 37 (20–77) | 39 (20–77) |
| No. (%) of women age: | |||
| ≥30 yr | 1,085 (83.5) | 221 (73.7) | 1,306 (81.6) |
| <30 yr | 215 (16.5) | 79 (26.3) | 294 (18.4) |
| No. (%) of women with the following cytology: | |||
| Normal cytology | 1,238 (95.2) | 0 (0.0) | 1,238 (77.4) |
| ASC-US | 31 (2.4) | 100 (33.3) | 131 (8.2) |
| LSIL | 13 (1.0) | 100 (33.3) | 113 (7.1) |
| ASC-H | 3 (0.2) | 0 (0.0) | 3 (0.2) |
| HSIL | 14 (1.1) | 100 (33.3) | 114 (7.1) |
| AGC | 1 (0.1) | 0 (0.0) | 1 (0.1) |
| No. (%) of women with the following histology: | |||
| No histology | 1,266 (97.4) | 80 (26.7) | 1,346 (84.1) |
| Normal histology | 4 (0.3) | 73 (24.3) | 77 (4.8) |
| CIN1 | 10 (0.8) | 40 (13.3) | 50 (3.1) |
| CIN2 | 9 (0.7) | 36 (12.0) | 45 (2.8) |
| CIN3 (including CIS) | 11 (0.8) | 69 (23.0) | 80 (5.0) |
| SCC | 0 (0.0) | 1 (0.3) | 1 (0.1) |
| Adenocarcinoma | 0 (0.0) | 1 (0.3) | 1 (0.1) |
| Total | 1,300 (100.0) | 300 (100.0) | 1,600 (100.0) |
a
The screening population included 1,300 subjects, and the enrichment population included 300 subjects. ASC-US, atypical squamous cells of undetermined significance; LSIL, low-grade squamous intraepithelial lesion; ASC-H, atypical squamous cells (the possibility of a high-grade squamous intraepithelial lesion cannot be excluded); HSIL, high-grade squamous intraepithelial lesion; AGC, atypical glandular cells; CIN, cervical intraepithelial neoplasia; CIS, carcinoma in situ; SCC, squamous cell carcinoma.