Table 3.
Best overall response (safety analysis set)
| Parameter | Patients with response, n (%) [95% confidence interval] |
|||
|---|---|---|---|---|
| Stratum 1 (n = 16) |
Stratum 2 (n = 8) |
Stratum 3 (n = 2) |
Overall (n = 26) |
|
| Response (CR + PR) rate | 1 (6.3) [0.2–30.2] |
0 [0.0–36.9] |
0 [0.0–84.2] |
1 (3.8) [0.1–19.6] |
| Best overall response | ||||
| CR | 0 [0.0–20.6] |
0 [0.0–36.9] |
0 [0.0–84.2] |
0 [0.0–13.2] |
| PR | 1 (6.3) [0.2–30.2] |
0 [0.0–36.9] |
0 [0.0–84.2] |
1 (3.8) [0.1–19.6] |
| SD | 8 (50.0) [24.7–75.3] |
3 (37.5) [8.5–75.5] |
1 (50.0) [1.3–98.7] |
12 (46.2) [26.6–66.6] |
| PD | 7 (43.8) [19.8–70.1] |
4 (50.0) [15.7–84.3] |
1 (50.0) [1.3–98.7] |
12 (46.2) [26.6–66.6] |
| NE | 0 [0.0–20.6] |
1 (12.5) [0.3–52.7] |
0 [0.0–84.2] |
1 (3.8) [0.1–19.6] |
Confirmed response according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1
Abbreviations: CR complete response, NE not evaluable, PD progressive disease, PR partial response, SD stable disease