Table 3. Incidence of ADR of the two medications.
| ADRs | DA-5204 (n = 215) | DA-9601 (n = 217) | P value |
|---|---|---|---|
| GI disorder | 0.283 | ||
| Belching | 4 (1.9) [4] | 1 (0.5) [1] | |
| Abdominal distension | 1 (0.5) [1] | 0 | |
| Constipation | 0 | 1 (0.5) [1] | |
| Dyspepsia | 1 (0.5) [1] | 0 | |
| Nausea | 1 (0.5) [1] | 0 | |
| Retching | 1 (0.5) [1] | 0 | |
| Parameter investigated | 0.499 | ||
| Alanine aminotransferase level | 0 | 1 (0.5) [1] | |
| Aspartate aminotransferase level | 0 | 1 (0.5) [1] | |
| Blood alkaline phosphatase level | 0 | 1 (0.5) [1] | |
| Abnormal liver function test results | 0 | 1 (0.5) [1] | |
| Total | 5 (2.3) [8] | 4 (1.8) [6] |
Data are presented as number of patients (%) and [number of cases].
ADR = adverse drug reaction, GI = gastrointestinal.