Distribution of the patients according to the average daily dose actually taken during the first 12 months or until failure and the rate of CCgR according to the average daily dose actually taken
| Average daily dose (mg) . | No. of patients (%) until failure . | No. of CCgRs (%) . | ||
|---|---|---|---|---|
| 800-mg arm . | 400-mg arm . | 800-mg arm . | 400-mg arm . | |
| 800 | 25 (28) | NA | 24/25 (96) | NA |
| 700-799 | 21 (23) | NA | 18/21 (86) | NA |
| 600-699 | 11 (12) | NA | 7/11 (64) | NA |
| 500-599 | 11 (12) | NA | 7/11 (64) | NA |
| 400-499 | 12 (13) | 56 (57) | 11/12 (92) | 37/56 (66) |
| 350-399 | 5 (6) | 30 (31) | 1/5 (20) | 23/30 (77) |
| Less than 350 | 5 (6) | 12 (12) | 1/5 (20) | 3/12 (27) |
| Total | 90 (100) | 98 (100) | 69/90 (77) | 63/98 (64) |
| Average daily dose (mg) . | No. of patients (%) until failure . | No. of CCgRs (%) . | ||
|---|---|---|---|---|
| 800-mg arm . | 400-mg arm . | 800-mg arm . | 400-mg arm . | |
| 800 | 25 (28) | NA | 24/25 (96) | NA |
| 700-799 | 21 (23) | NA | 18/21 (86) | NA |
| 600-699 | 11 (12) | NA | 7/11 (64) | NA |
| 500-599 | 11 (12) | NA | 7/11 (64) | NA |
| 400-499 | 12 (13) | 56 (57) | 11/12 (92) | 37/56 (66) |
| 350-399 | 5 (6) | 30 (31) | 1/5 (20) | 23/30 (77) |
| Less than 350 | 5 (6) | 12 (12) | 1/5 (20) | 3/12 (27) |
| Total | 90 (100) | 98 (100) | 69/90 (77) | 63/98 (64) |
The data of the patients who dropped out or went off treatment for AE or SAE (18 in the high-dose arm and 10 in the standard-dose arm) are not included. The median average daily dose was 720 mg in the 800-mg arm and 400 mg in the 400-mg arm. In the high-dose arm 24 of 25 patients who could tolerate the assigned 800-mg dose achieved a CCgR, and only 2 of 10 patients who could take less than 400 mg achieved a CCgR. In the standard-dose arm, the CCgR rate was alike in the patients who could take the assigned 400-mg dose (66%), and in the patients who underwent a small dose reduction (350-399 mg; 77%). In both arms, the patients who could take only less than 350 mg daily rarely achieved a CCgR. There is an impressive difference between the CCgR rate of the patients who could tolerate 350-399 mg in the high-dose arm (1 of 5 patients, or 20%) and in the standard-dose arm (23 of 30 patients, or 77%). This may be simply accounted by small numbers, but it could be explained also because the 5 patients in the high-dose arm were treated discontinuously, whereas the 30 patients in the standard-dose arm were treated more continuously.