Table 3.
Number of Subjects (by Cohort) with ≥1 Grade 1 Infusion Site Findinga
| Cohorts |
||||||||
|---|---|---|---|---|---|---|---|---|
| Dose/infusion time | 1 | 2 | 3 | 4 | 5 | 6 | 7 | |
| 12 mg/2 min | 18 mg/2 min | 24 mg/2 min | 24 mg/1 min | 24 mg/30 s | 36 mg/30 s | 48 mg/30 s | Total (%) | |
| Placebo (N = 2 each) | 1 of 2 | 1 of 2b | 0 of 2 | 1 of 2 | 0 of 2 | 0 of 2 | 0 of 2 | 3 of 14 (21%) |
| Female | 1 of 2 | 1 of 2b | NA | 0 of 1 | NA | NA | NA | 2 of 5 (40%) |
| Male | NA | NA | 0 of 2 | 1 of 1 | 0 of 2 | 0 of 2 | 0 of 2 | 1 of 9 (11%) |
| Vestipitant (N = 6 each)c | 4 of 6 | 4 of 5 | 3 of 6 | 2 of 6 | 0 of 6 | 1 of 6 | 0 of 6 | 14 of 41 (34%) |
| Female | 4 of 4 | 4 of 5b | 1 of 2 | 2 of 4 | NA | NA | NA | 11 of 15 (73%) |
| Male | 0 of 2 | NA | 2 of 4 | 0 of 2 | 0 of 6 | 1 of 6 | 0 of 6 | 3 of 26 (12%) |
NA, not applicable.
a
All Infusion Site Findings were Grade 1–no Grade 2 or Grade 3.
b
Includes 1 subject whose findings were also observed pre-dose.
c
Only 5 subjects received vestipitant in Cohort 2.