Table 3.
Quantitative Summary of Safety Findings in RTI Nonhuman Primate Study
| Implant formulation/dose | Duration (weeks) | Grade 0 local reactivitya | Grades 1–2 local reactivitya | Grades 3–4 local reactivitya |
|---|---|---|---|---|
| No. 1/0.16 mg per dayb | 8 | 7/21 (33%) | 13/21 (62%) | 1/21 (5%) |
| No. 2/0.35 mg per dayc | 11–12 | 14/62 (23%) | 39/62 (63%) | 9/62 (14%) |
| No. 3/0.70 mg per day | 20 | 57/114 (50%) | 46/114 (40%) | 11/114 (10%) |
a
Denominators listed in these columns are the total number of cage side observations per implant dose group.
b
Implant failure (n = 1, week 5).
c
Implant came out of animal (n = 1, week 5).