Table 2.
Adverse Events
| Points, No. | Grade | ||
|---|---|---|---|
|
|
|
||
| Serious Adverse Events | 3 | ||
| Hospitalization, search for primary tumor | 1 | 4 | |
| Infection, lung | 1 | 4 | |
| Ataxia and weakness | 1 | 4 | |
| Infectious Adverse Events | 2 | ||
| Oral abscess | 1 | 3 | |
| Oral herpes simplex | 1 | 2 | |
|
Adverse Events (Grade 1 or 2) Occurring in >3 Patients |
Points, No. (%) | 95% CI | Reported Ranges, % |
| Tacrolimus, high | 13 (50) | 30–70 | |
| Headache | 12 (46) | 27–67 | 37–64 |
| BUN, high | 10 (38) | 20–59 | 30 |
| High blood pressure | 9 (35) | 17–56 | 38–50 |
| Glucose, high | 7 (27) | 12–48 | 22–47 |
| Nausea | 7 (27) | 12–48 | 32–46 |
| Total protein, low | 7 (27) | 12–48 | 3 |
| Albumin, low | 6 (23) | 9–44 | Reported |
| Dizziness | 6 (23) | 9–44 | 19 |
| Hematocrit, low | 5 (19) | 7–39 | 5–47 |
| Vomiting | 5 (19) | 7–39 | 14–29 |
| Fatigue | 4 (15) | 4–35 | Reported |
| Tremors | 4 (15) | 4–35 | 48–56 |
Abbreviation: BUN, blood urea nitrogen.