Table 2.
ORR and best response based on investigator/assessment (primary efficacy analysis set; n = 15)
| n (%) | 95% CIa | |
|---|---|---|
| ORRb: CR + PR | 13 (86.7) | 59.5–98.3 |
| Best response | ||
| CR | 4 (26.7) | 7.8–55.1 |
| PR | 9 (60.0) | 32.3–83.7 |
| SD | 1 (6.7) | 0.2–31.9 |
| PD | 1 (6.7) | 0.2–31.9 |
| Not evaluable | 0 (0.0) | 0.0–21.8 |
CI confidence interval, CR complete response, IWG International Working Group, ORR objective response rate, PD progressive disease, PR partial response, SD stable disease
aBased on the Clopper–Pearson method
bBased on investigator assessment per the IWG 2007 criteria