Table 4. Observed Toxicities by Treatment Arm (Randomized Population) and in the Crossover Treatment Population.
| Observed Toxicities by Treatment Arm (Randomized Population) | Docetaxel (N=64) Grade | Docetaxel + Vandetanib (N=61) Grade | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | ||
| Hematologic | |||||||||||
| Anemia | 29 | 16 | 1 | 0 | 0 | 17 | 9 | 2 | 0 | 0 | |
| Febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | |
| Leukocytosis | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | |
| Neutrophil count decreased | 0 | 3 | 17 | 15 | 0 | 0 | 3 | 8 | 20 | 0 | |
| Platelet count decreased | 6 | 0 | 0 | 0 | 0 | 5 | 2 | 1 | 0 | 0 | |
| White blood cell decreased | 4 | 10 | 17 | 3 | 0 | 2 | 4 | 17 | 3 | 0 | |
| Non-Hematologic | |||||||||||
| Allergic reaction | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | |
| Alopecia | 12 | 31 | 0 | 0 | 0 | 5 | 27 | 0 | 0 | 0 | |
| Anorexia | 5 | 10 | 1 | 0 | 0 | 10 | 5 | 2 | 0 | 0 | |
| Constipation | 15 | 7 | 0 | 0 | 0 | 10 | 4 | 1 | 0 | 0 | |
| ECG QT corrected interval prolonged | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | |
| Edema | 9 | 2 | 1 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | |
| Elevated Liver Function Tests | 8 | 0 | 0 | 0 | 0 | 13 | 0 | 0 | 0 | 0 | |
| Fatigue/Malaise | 25 | 17 | 6 | 0 | 0 | 12 | 19 | 5 | 0 | 0 | |
| Hand-Foot syndrome | 4 | 4 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | |
| Hypertension | 0 | 0 | 0 | 0 | 0 | 1 | 7 | 0 | 0 | 0 | |
| Hypocalcemia | 4 | 1 | 2 | 0 | 0 | 6 | 3 | 0 | 1 | 0 | |
| Hypokalemia | 8 | 0 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | |
| Hypomagnesemia | 11 | 3 | 0 | 1 | 0 | 19 | 2 | 1 | 1 | 0 | |
| Mucositis oral | 15 | 5 | 0 | 1 | 0 | 8 | 9 | 1 | 0 | 0 | |
| Myalgia | 3 | 7 | 0 | 0 | 0 | 10 | 4 | 0 | 0 | 0 | |
| Nail disorders | 14 | 4 | 0 | 0 | 0 | 9 | 1 | 1 | 0 | 0 | |
| Nausea/Vomiting | 22 | 7 | 5 | 0 | 0 | 19 | 8 | 3 | 0 | 0 | |
| Neuropathy | 25 | 5 | 3 | 0 | 0 | 19 | 0 | 0 | 0 | 0 | |
| Proteinuria | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Rash | 8 | 3 | 0 | 0 | 0 | 13 | 11 | 6 | 0 | 0 | |
| Thromboembolic event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | |
| Treatment-related secondary malignancy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | |
| Observed Toxicities during Crossover Treatment with Vandetanib | Vandetanib (N=33) Grade | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |
| Hematologic | |||||
| Anemia | 9 | 2 | 0 | 0 | 0 |
| Neutrophil count decreased | 1 | 0 | 0 | 0 | 0 |
| White blood cell decreased | 2 | 0 | 0 | 0 | 0 |
| Non-Hematologic | |||||
| Alopecia | 2 | 6 | 0 | 0 | 0 |
| Anorexia | 2 | 1 | 1 | 0 | 0 |
| Constipation | 5 | 4 | 0 | 0 | 0 |
| Elevated Liver Function Tests | 5 | 1 | 0 | 0 | 0 |
| Fatigue/Malaise | 11 | 5 | 1 | 0 | 0 |
| Hand-Foot syndrome | 1 | 1 | 0 | 0 | 0 |
| Hypertension | 1 | 0 | 2 | 0 | 0 |
| Hypokalemia | 1 | 0 | 0 | 1 | 0 |
| Hypomagnesemia | 5 | 1 | 0 | 0 | 0 |
| Mucositis oral | 0 | 1 | 0 | 0 | 0 |
| Myalgia | 4 | 1 | 1 | 0 | 0 |
| Nail disorders | 2 | 0 | 0 | 0 | 0 |
| Nausea/Vomiting | 5 | 1 | 1 | 0 | 0 |
| Neuropathy | 8 | 0 | 0 | 0 | 0 |
| Proteinuria | 1 | 0 | 0 | 0 | 0 |
| Rash | 0 | 1 | 0 | 0 | 0 |