TABLE 3.
Incidence of axonopathy in the sciatic nerves and spinal cords in monkeys following once daily oral administration for 9 months
| Site | Interval | Incidence of axonopathy by sex and dose (mg/kg/day)a
|
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Males
|
Females
|
||||||||
| 0 | 500 | 1,000 | 2,000 | 0 | 500 | 1,000 | 2,000 | ||
| Sciatic nerve | 3 mo | 0/3 | 0/3 | 0/3 | 1/3 (G1) | 0/3 | 0/3 | 0/3 | 1/3 (G1); 1/3 (G2) |
| 9 mo | 1/4 (G1) | 2/4 (G1) | 0/4 | 0/4 | 2/4 (G1) | 2/4 (G1) | 0/4 | 3/4 (G1) | |
| Recovery | 0/2 | NA | NA | 1/2 (G1) | 0/2 | NA | NA | 0/2 | |
| Spinal cord | 3 mo | 0/3 | 2/3 (G1) | 1/3 (G1) | 1/3 (G1) | 1/3 (G1); 1/3 (G2) | 1/3 (G1) | 1/3 (G1); 1/3 (G2) | 0/3 |
| 9 mo | 0/4 | 1/4 (G1) | 1/4 (G1) | 2/4 (G1); 1/4 (G2) | 2/4 (G1) | 0/4 | 1/4 (G1) | 1/4 (G1) | |
| Recovery | 0/2 | NA | NA | 0/2 | 0/2 | NA | NA | 0/2 | |
a
Abbreviations: NA, not applicable; G1, grade 1, minimal, one fiber was affected in the tissue sections examined; G2, grade 2, mild, two to four fibers were affected in the tissue sections examined.