Table 3.
Summary of adverse events, serious AEs of all groups
| Items | Placebo (N = 85) | 600 mg (N = 84) | 900 mg (N = 86) | p value |
|---|---|---|---|---|
| Cases (%) | Cases (%) | Cases (%) | ||
| AEs | 35 (41.2) | 31 (36.9) | 24 (27.9) | 0.18 |
| NR Med | 32 (37.7) | 26 (30.9) | 21 (24.4) | 0.17 |
| RE Med | 3 (3.5) | 5 (6.0) | 3 (3.5) | 0.67 |
| SAEs | 6 (7.1) | 5 (6.0) | 3 (3.5) | 0.58 |
| NR Med | 6 (7.1) | 4 (4.8) | 3 (3.5) | 0.56 |
| RE Med | 0 (0.0) | 1 (1.2) | 0 (0.0) | 0.36 |
| Drop-off due to AE | 1 (1.2) | 3 (3.6) | 3 (3.5) | 0.56 |
AEs adverse events, SAEs serious AEs, AEs NR Med non-medication-related AEs, AEs RE Med medication-related AEs (definitely, probable, possible, and suspiciously)
p values related to AE and SAE were analyzed using the chi-squared test