Table 4.
Reasons for Treatment Termination by Treatment Arm
| Reason | Step |
|||||
|---|---|---|---|---|---|---|
| Run-In (n = 29) |
Random Assignment |
|||||
| No. of Patients | % | Placebo (n = 398) |
Selenium (n = 795) |
|||
| No. of Patients | % | No. of Patients | % | |||
| Completed treatment | — | — | 134 | 33.7 | 238 | 29.9 |
| Progressive disease | — | — | 52 | 13.1 | 117 | 14.7 |
| Excessive complication/toxicity | — | — | 8 | 2 | 20 | 2.5 |
| Death without progressive disease | — | — | 12 | 3 | 18 | 2.3 |
| Patient withdrawal or refusal | 20 | 69 | 67 | 16.8 | 157 | 19.8 |
| Patient started nonprotocol therapy | — | — | 3 | < 1 | 1 | < 1 |
| Other complicating disease | 1 | 3.4 | 17 | 4.3 | 30 | 3.8 |
| Maximum dose reached | — | — | 0 | 0 | 2 | < 1 |
| Other | 8 | 27.6 | 105 | 26.4 | 212 | 26.7 |