Table 8.
Microscopic findings in dogs at the end of treatment period
| Tissue | Microscopic Observation | Male | Female | ||||||
|---|---|---|---|---|---|---|---|---|---|
| 0 mg/kg N=3 | 5 mg/kg N=3 | 20 mg/kg N=3 | 75 mg/kg N=2 | 0 mg/kg N=3 | 5 mg/kg N=3 | 20 mg/kg N=3 | 75 mg/kg N=3 | ||
| AUClast (hr*ng/mL) on Day 28 | 0 | 2650 | 4250 | 3220 | 0 | 4940 | 3340 | 2680 | |
| Duodenum | Chronic-active inflammation | ||||||||
| Minimal | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | |
| Jejunum | Lymphoid tissue hyperplasia | ||||||||
| Minimal | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | |
| Chronic-active inflammation | |||||||||
| Minimal | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | |
| Ileum | Lymphoid tissue hyperplasia | ||||||||
| Minimal | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Mild | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | |
| Chronic-active inflammation | |||||||||
| Mild | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | |
| Colon | Lymphoid tissue hyperplasia | ||||||||
| Minimal | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | |
| Pancreas | Single cell necrosis | ||||||||
| Minimal | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | |
| Thymus | Cortical Atrophy | ||||||||
| Minimal | 0 | 2 | 1 | 1 | 1 | 2 | 1 | 1 | |
| Mild | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | |
| Moderate | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | |
| Testes | Degeneration | NA | NA | NA | NA | ||||
| Minimal | 1 | 1 | 0 | 0 | |||||
| Mild | 0 | 0 | 1 | 1 | |||||
| Moderate | 0 | 0 | 2 | 0 | |||||
The numbers indicate number of animals affected in the group