Table 4 Summary of adverse events
From: Safety and pharmacokinetics of a highly bioavailable resveratrol preparation (JOTROL TM)
Part 1 | Part 2 | Overall | |||
|---|---|---|---|---|---|
Treatment A | Treatment B | Treatment C | Treatment D | ||
Number of subjects dosed, N | 21 | 16 | 18 | 15 | 24 |
Number of subjects with at least one TEAE, N (%) | 7 (33.3%) | 4 (25.0%) | 6 (33.3%) | 6 (40.0%) | 15 (62.5%) |
Number of TEAEs, n | 9 | 4 | 6 | 6 | 25 |
Number of serious TEAEs, n | 0 | 0 | 0 | 0 | 0 |
Number of severe TEAEs, n | 0 | 0 | 0 | 0 | 0 |
Number of related TEAEsa, n | 6 | 3 | 1 | 3 | 13 |
Number of subjects who discontinued due to TEAEs, n (%) | 3 (60.0%) | 0 | 1 (33.3%) | 0 | 4 (40.0%) |
Number of subjects who discontinued permanently due to non-TEAEs, n (%) | 1 (11.1%) | 0 | 0 | 0 | 1 (4.2%) |
Number of deaths, n | 0 | 0 | 0 | 0 | 0 |