Table 1.
Active surveillance system for herbs safety: top 20 adverse events detected by the panel of investigators and study nurses during the study period.
| Adverse events | Risk* | |||||
|---|---|---|---|---|---|---|
| Suan Zao Ren Tang | Duhuo Jisheng Tang | TMN-1 | ||||
| /103 person-daysa | /103 person-sachetsa | /103 person-daysb | /103 person-sachetsb | /103 person-daysc | /103 person-sachetsc | |
| Body as a whole | ||||||
| Abdominal pain | 1.8 | 0.6 | 8.3 | 4.4 | 1.8 | 0.6 |
| Abdominal fullness | 4.2 | 1.4 | 12.9 | 6.9 | 1.7 | 0.6 |
| Dizziness | 1.8 | 0.6 | ||||
| Chest pain | 0.6 | 0.2 | 3.1 | 1.7 | 0.3 | 0.1 |
| Fever | 0.6 | 0.2 | 1.0 | 0.2 | 0.2 | 0.1 |
| Somnolence | — | — | 11.9 | 6.3 | — | — |
| Musculoskeletal system | ||||||
| Muscle cramps | — | — | 10.3 | 5.5 | 0.1 | 0.1 |
| Headache | 1.8 | 0.6 | 4.6 | 2.5 | — | — |
| Respiratory system | ||||||
| Cough | 3.0 | 1.0 | 12.4 | 6.6 | 2.6 | 0.9 |
| Rhinitis | 1.8 | 0.6 | 8.3 | 4.4 | 1.9 | 0.7 |
| Pharyngitis | 1.8 | 0.6 | 8.3 | 4.4 | 2.5 | 0.9 |
| Digestive system | ||||||
| Diarrhea | 3.6 | 1.2 | 10.3 | 5.5 | 1.6 | 0.6 |
| Nausea | 1.2 | 0.4 | 3.1 | 1.7 | 0.8 | 0.3 |
| Vomit | 0.6 | 0.2 | 0.5 | 0.3 | 0.3 | 0.1 |
| Oral ulcer | — | — | 1.5 | 0.8 | 0.2 | 0.1 |
| Stomachache | 0.6 | 0.2 | — | — | 0.5 | 0.2 |
| Skin and appendages | ||||||
| Urticaria | — | — | 0.5 | 0.3 | 0.1 | 0.0 |
| Pruritus | 0.6 | 0.2 | — | — | 1.6 | 0.6 |
| Skin discolor | — | — | 0.5 | 0.3 | 0.3 | 0.1 |
| Rash | 0.6 | 0.2 | 14.5 | 7.7 | 0.8 | 0.3 |
*Number of cases was used as the numerator for calculation of risk.
aThe denominators for the calculation of the risks were 1,691 person-days and 5,122 person-sachets.
bThe denominators for the calculation of the risks were 1,936 person-days and 3,633 person-sachets.
cThe denominators for calculation of risks were 10,133 person-days and 28,744 person-sachets.