Table 7.
Summarized results of safety test (safety set).
| SRS + OB (n = 20) |
SRS + P-OB (n = 20) |
P-SRS + OB (n = 20) |
P-SRS + P-OB (n = 20) |
p-Value | |
|---|---|---|---|---|---|
| AE (n; %) | 6 (30.00) | 7 (35.00) | 5 (25.00) | 8 (40.00) | 0.778 a |
| ADR (n; %) | 1 (5.00) | 0 (0.00) | 0 (0.00) | 1 (5.00) | 1.000 b |
| SAE (n; %) | 0 (0.00) | 0 (0.00) | 1 (5.00) | 2 (10.00) | 0.610 b |
| SADE (n; %) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 1 (5.00) | 1.000 b |
a: Chi-square test, b: Fisher’s exact test. SRS = Samryungbaekchul-san; OB = otilonium bromide; P = placebo. AE = adverse events; ADR = adverse drug reaction; SAE = serious adverse event; SADE = serious adverse drug event.