Table 5.
Summary of AEs by Maximum Grade Reported
| A. Single Ascending Dose | |||||
|---|---|---|---|---|---|
| Placebo (N = 8) n (%) | Cohort A GSK3389404 10 mg (N = 6) n (%) | Cohort B GSK3389404 30 mg (N = 6) n (%) | Cohort C GSK3389404 60 mg (N = 6) n (%) | Cohort D GSK3389404 120 mg (N = 6) n (%) | |
| AE | 4 (50) | 3 (50) | 2 (33) | 3 (50) | 5 (83) |
| Grade 1 | 3 (38) | 0 | 1 (17) | 1 (17) | 4 (67) |
| Grade 2 | 1 (13) | 3 (50) | 1 (17) | 2 (33) | 1 (17) |
| Grades 3–5 | 0 | 0 | 0 | 0 | 0 |
| AE leading to study withdrawal | 0 | 0 | 0 | 0 | 0 |
| Serious AE | 0 | 0 | 0 | 0 | 0 |
| Grades 3–4 laboratory abnormality | 0 | 0 | 0 | 1 (17) | 0 |
| B. Multiple ascending dose | ||||
|---|---|---|---|---|
| Placebo (QW × 4 weeks) (N = 6) n (%) | Cohort E GSK3389404 30 mg (QW × 4 weeks) (N = 6) n (%) | Cohort F GSK3389404 60 mg (QW × 4 weeks) (N = 6) n (%) | Cohort G GSK3389404 120 mg (QW × 4 weeks) (N = 6) n (%) | |
| AE | 3 (50) | 5 (83) | 2 (33) | 4 (67) |
| Grade 1 | 2 (33) | 2 (33) | 0 | 2 (33) |
| Grade 2 | 1 (17) | 3 (50) | 2 (33) | 2 (33) |
| Grade 3–5 | 0 | 0 | 0 | 0 |
| AE leading to study withdrawal | 0 | 0 | 0 | 0 |
| Serious AE | 0 | 0 | 0 | 0 |
| Grades 3–4 laboratory abnormality | 0 | 0 | 0 | 0 |
Safety population: defined as all subjects who received ≥1 dose of GSK3389404 or placebo. Data are for the number of subjects reporting ≥1 AE. AE indicates adverse event; QW, once weekly. Grades 3–4 laboratory abnormality is from ad hoc analysis.