Table 5. The frequency and incidence of the likely related ADRs for patients using Yunnan Baiyao capsule.
| Likely ADRs | Frequency | Incidence (PP, %) | Incidence (ITT, %) |
|---|---|---|---|
| Nausea and vomiting | 56 | 0.1785 | 0.7764 |
| Functional diarrhea | 37 | 0.1180 | 0.7162 |
| Stomach discomfort | 28 | 0.0893 | 0.6877 |
| Rash | 18 | 0.0574 | 0.6560 |
| Gastro-esophageal reflux disease | 12 | 0.0383 | 0.6370 |
| Allergic dermatitis | 10 | 0.0319 | 0.6306 |
| Epigastric pain | 9 | 0.0287 | 0.6275 |
| Chest distress | 8 | 0.0255 | 0.6243 |
| Flatulence | 7 | 0.0223 | 0.6211 |
| Pruritus | 6 | 0.0191 | 0.6179 |
| Palpitation | 5 | 0.0159 | 0.6148 |
| Anorexia | 4 | 0.0128 | 0.6116 |
| Lower abdomen pain | 4 | 0.0128 | 0.6116 |
| Dizziness | 4 | 0.0128 | 0.6116 |
| Fever | 2 | 0.0064 | 0.6053 |
| Toxic effect of alcohol | 2 | 0.0064 | 0.6053 |
| Eczema | 2 | 0.0064 | 0.6053 |
| Shortness of breath | 1 | 0.0032 | 0.6021 |
| Halitosis | 1 | 0.0032 | 0.6021 |
| Asthenia | 1 | 0.0032 | 0.6021 |
| Total | 217 | 0.6918 | 1.2866 |
ADR, adverse drug reaction; PP, per-protocol; ITT, intention-to-treat.