TABLE A1.
Response End Points
| End Point | Subcutaneous Group (n = 206) | Intravenous Group (n = 212) |
|---|---|---|
| Objective responsea | ||
| Patients including all responders, % (95% CI) | 30 (24 to 37) | 33 (26 to 39) |
| Patients including only confirmed responders, % (95% CI) | 27 (21 to 33) | 27 (21 to 33) |
| Best overall response, No. (%)a | ||
| Complete responseb | 1 (0.5) | 1 (0.5) |
| Partial responseb | 61 (30) | 68 (32) |
| Stable disease | 93 (45) | 81 (38) |
| Progressive disease | 37 (18) | 42 (20) |
| Not evaluable | 14 (7) | 20 (9) |
| Disease control rate, % (95% CI)c | 75 (69 to 81) | 71 (64 to 77) |
| DoR | ||
| Median among all responders, months (95% CI) | 11.2 (6.1 to NE) | 7.1 (5.3 to NE) |
| Median among confirmed responders, months (95% CI) | 11.2 (6.1 to NE) | 8.3 (5.4 to NE) |
| Time to response | ||
| Median, months (range) | 1.5 (1.2-6.9) | 1.5 (1.2-9.9) |
NOTE. The efficacy population included all the patients who had undergone random assignment.
Abbreviations: DoR, response duration; NE, not estimable.
a
The objective response (complete or partial response as best response) was assessed using RECIST, v1.1 and analyzed using logistic regression.
b
Among all responders.
c
Not protocol-specified; calculated as the sum of complete response, partial response, and stable disease; all responders were included.