Table 2. Current Status and Reasons for Removal from Protocol Treatment.
Initial Registration | Crossover Treatment with Vandetanib following Progression on Docetaxel Arm | |||
---|---|---|---|---|
Treatment Result | TOTAL | Docetaxel | Docetaxel + Vandetanib | Vandetanib |
NUMBER ON PROTOCOL TREATMENT | 1 | 1 | 0 | 0 |
NUMBER OFF PROTOCOL TREATMENT | 128 | 65 | 63 | 33 |
REASON OFF TREATMENT | ||||
Adverse events or side effects | 22 | 7 | 15 | 1 |
Refusal unrelated to adverse event | 13 | 8 | 5 | 1 |
Progression/relapse | 82 | 47 | 35 | 30 |
Death | 0 | 0 | 0 | 0 |
Other-not protocol specified | 11 | 3 | 8 | 1 |
MAJOR PROTOCOL DEVIATIONS | 4 | 2 | 2 | 0 |