Maximum dose of study drug, according to treatment arm
| Percent of prescribed dose . | Thalidomide no. (%) . | Placebo no. (%) . |
|---|---|---|
| 25 | 13 (52) | 2 (8) |
| 50 | 4 (16) | 9 (35) |
| 75 | 1 (4) | 1 (4) |
| 100 | 7 (28) | 14 (54) |
| Percent of prescribed dose . | Thalidomide no. (%) . | Placebo no. (%) . |
|---|---|---|
| 25 | 13 (52) | 2 (8) |
| 50 | 4 (16) | 9 (35) |
| 75 | 1 (4) | 1 (4) |
| 100 | 7 (28) | 14 (54) |
The maximum administered daily dose at any time after randomization was calculated as a percentage of the prescribed daily target dose. Three of the 7 patients who reached 100% of the prescribed target dose of thalidomide later had to reduce the dose because of toxicity. None of the 14 patients who reached 100% of the prescribed target dose of placebo had toxicity that led to reduction of the dose. The P value for trend was .005.