Table 2.
Summary of Adverse Events Reported in ≥2 Subjects, Regardless of Causality
Vestipitant cohort |
|||||||||
---|---|---|---|---|---|---|---|---|---|
Preferred term, n (%) | 1 (N = 6) | 2 (N = 5) | 3 (N = 6) | 4 (N = 6) | 5 (N = 6) | 6 (N = 6) | 7 (N = 6) | ||
Infusion | Total (N = 55) | Placebo (N = 14) | 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 |
Subjects with any AE | 31 (56) | 8 (57) | 5 (83) | 5 (100) | 4 (67) | 3 (50) | 1 (17) | 3 (50) | 2 (33) |
Subject with any related AE | 25 (45) | 6 (43) | 4 (67) | 5 (100) | 4 (67) | 2 (33) | 1 (17) | 1 (17) | 0 |
Infusion site pain | 5 (9) | 0 | 1 (17) | 1 (20) | 2 (33) | 1 (17) | 0 | 0 | 0 |
Infusion related reaction | 5 (9) | 0 | 3 (50) | 1 (20) | 0 | 0 | 0 | 0 | 1 (17) |
Infusion site hematoma | 5 (9) | 2 (14) | 0 | 1 (20) | 2 (33) | 0 | 0 | 0 | 0 |
Headache | 5 (9) | 1 (7) | 1 (17) | 1 (20) | 1 (17) | 1 (17) | 0 | 0 | 0 |
Lethargy | 4 (7) | 0 | 0 | 2 (40) | 0 | 0 | 0 | 2 (33) | 0 |
Procedural dizziness | 3 (5) | 0 | 1 (17) | 1 (20) | 0 | 1 (17) | 0 | 0 | 0 |
Somnolence | 3 (5) | 2 (14) | 0 | 0 | 0 | 0 | 1 (17) | 0 | 0 |
Dysgeusia | 2 (4) | 0 | 0 | 0 | 0 | 1 (17) | 1 (17) | 0 | 0 |
Infusion site discomfort | 2 (4) | 0 | 0 | 0 | 0 | 1 (17) | 0 | 1 (17) | 0 |
Myalgia | 2 (4) | 0 | 1 (17) | 0 | 0 | 1 (17) | 0 | 0 | 0 |
Upper respiratory tract infection | 2 (4) | 0 | 2 (33) | 0 | 0 | 0 | 0 | 0 | 0 |
Abdominal pain | 2 (4) | 1 (7) | 0 | 0 | 0 | 1 (17) | 0 | 0 | 0 |