Table 2.
Relapse and/or recurrence rates in the three treatment arms over 8, 20, and 32 months post-randomization.
| Time since randomization |
Rate of Relapse/Recurrence | Log- rank |
p- value |
Hazard Ratio † (95% CI) |
|||
|---|---|---|---|---|---|---|---|
| PBO | FLX | C-CT | FLX or CCT |
||||
| 8 Months | 32.7% | 18.0% | 18.3% | 18.3% | |||
| FLX vs. C-CT | 0.038 | .42 | 1.079 (0.50, 2.34) | ||||
| PBO vs. FLX | 3.916 | .02 | 0.481 (0.23, 1.01) | ||||
| PBO vs. C-CT | 3.391 | .03 | 0.519 (0.26, 1.06) | ||||
| PBO vs. FLX or C-CT | 5.057 | .01 | 0.501 (0.27, 0.93) | ||||
| 20 Months | 42.7% | 35.1% | 35.0% | 35.1% | |||
| FLX vs. C-CT | 0.002 | .48 | 0.988 (0.55, 1.76) | ||||
| PBO vs. FLX | 1.190 | .14 | 0.717 (0.39, 1.31) | ||||
| PBO vs. C-CT | 1.262 | .13 | 0.715 (0.40, 1.29) | ||||
| PBO vs. FLX or C-CT | 1.595 | .10 | 0.717 (0.43, 1.20) | ||||
| 32 Months | 56.3% | 41.1% | 45.2% | 43.2% | |||
| FLX vs. C-CT | 0.070 | .40 | 1.075 (0.63, 1.84) | ||||
| PBO vs. FLX | 2.407 | .61 | 0.649 (0.37, 1.13) | ||||
| PBO vs. C-CT | 1.731 | .09 | 0.701 (0.41, 1.19) | ||||
| PBO vs. FLX or C-CT | 2.705 | .05 | 0.676 (0.42, 1.08) | ||||
†
: Hazard ratios for the category listed second; CI: Confidence interval.