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.