Table 3.
Toxicity profile
| BP (mm Hg) |
Hct (vol%) |
AST (U/mL) |
ALT (U/mL) |
|||||
|---|---|---|---|---|---|---|---|---|
| Patient ID |
Wk 0 |
Wk 16 |
Week 0 |
Week 16 |
Week 0 |
Week 16 |
Week 0 |
Week 16 |
| 1 | 104/64 | 112/60 | 38.4 | 32.4 | 26 | 26 | 22 | 21 |
| 2 | 148/95 | 132/89 | 30.3a | 33.5 | 23 | 36 | 10 | 14 |
| 3 | 96/64 | 117/86 | 34.5 | 36.4 | 20 | 24 | 21 | 24 |
| 4 | 85/58 | 129/78 | 34.9 | 35.7 | 26 | 27 | 14 | 26 |
| 5 | 97/70 | 110/65 | 33.4 | 31.6 | 34 | 26 | 26 | 27 |
| 6 | 111/74 | 99/64 | 26.0 | 34.8 | 18 | 16 | 28 | 24 |
| 7 | 97/56 | 111/71 | 42.2 | 43.5 | 19 | 29 | 34 | 36 |
| 8 | 126/60 | 109/63 | 40.3 | 36.3 | 37 | 24 | 29 | 28 |
| 9 | 124/86 | 98/58 | 29.3 | 25.1 | 41 | 39 | 28 | 17 |
| 10 | 118/80 | 110/62 | 36.4 | 36.0 | 24 | 24 | 16 | 14 |
| Mean ± SD |
111±19/ 71±13 |
113±11/ 70±11 |
34.6± 5.1 |
34.5± 4.6 |
27±8 | 27±6 | 23±8 | 23±7 |
| P value | 0.8/0.9 | 0.9 | 0.9 | 0.9 | ||||
Note: ANA titer results were negative for all patients at both the 0 and 16-week timepoints (P = 0.9).
a
Hematocrit was measured at study week 2