Table 3.
Enrollment histology | |||
---|---|---|---|
Outcomea | Overall N (%)a |
Normal Histology N (%)a |
CIN1 N (%)a |
Total | 343 | 226 | 117 |
Progression to high-grade a | 24 (7.0) | 14 (6.2) | 10 (8.5) |
CIN2 | 9 (2.6) | 5 (2.2) | 4 (3.4) |
CIN2–3 | 4 (1.2) | 1 (0.4) | 3 (2.6) |
CIN3 | 3 (0.9) | 3 (1.3) | 0 |
HSIL | 3 (0.9) | 1 (0.4) | 2 (1.7) |
ASC-H | 4 (1.2) | 3 (1.3) | 1 (0.9) |
LSIL-H | 1 (0.3) | 1 (0.4) | 0 |
No progression to high-grade | 319 (93.0) | 212 (93.8) | 107 (91.5) |
Normal | 245 (71.4) | 172 (76.1) | 73 (62.4) |
CIN1 | 11 (3.2) | 3 (1.3) | 8 (6.8) |
ASCUS | 40 (11.7) | 19 (8.4) | 21 (17.9) |
LSIL | 23 (6.7) | 18 (8.0) | 5 (4.3) |
Percentages are column percentages.
Participants counted as “progressed” on first instance of a progression event, Histology was preferred over cytology to categorize progression events, but cytology alone was used in the absence of confirmatory histology. Of the progression events, 6 eventually progressed to CIN3 later in follow-up (3 CIN2, 2 ASC-H, and 1 HSIL); however, all were counted as “progression” events earlier in their disease course per study protocol.