Table 2.
Results in the full analysis set (FAS)
| FAS | CA group (n = 41/lesion = 42) | AHC group (n = 40/lesion = 41) | 95% confidence interval | P‐value |
|---|---|---|---|---|
| Primary endpoint | ||||
| ICR | (99.24 ± 2.18)% | (98.66 ± 3.79)% | 0.394 | |
| Difference between groups | 10.58% | 9.24%–11.9% | ||
| DCR | 40 (97.6%) | 38 (95%) | ||
| Difference between groups | 3.3% | −4.7%–12.1% | ||
| Response rate n (%) | 0.463 | |||
| CR | 17 (41.5%) | 11 (27.5%) | ||
| PR | 22 (53.7%) | 24 (60%) | ||
| SD | 1 (2.4%) | 3 (7.5%) | ||
| PD | 1 (2.4%) | 2 (5%) | ||
| Secondary endpoint | ||||
| Satisfaction with the device | 100% | 100% | NA | |
| Pain score | 0.46 ± 0.87 | 0.68 ± 1.07 | 0.331 | |
| Difference in QOL before and after procedure | 13.47 ± 4.49 | 15.22 ± 5.05 | 0.130 | |
CR, complete response; DCR, disease control rate; ICR, iceball coverage rate; PD, progressive disease; PR, partial response; QOL, quality of life; SD, stable disease.