Table 2

Probable adverse drug reactions detected by the panel of investigators (Chinese medical doctors) and study nurses

Cases adjudged by the panel to be probable ADRs

Judgment by study nurses under the Naranjo scale

Subjective judgment of the investigators

Risk per 10³ person-days^a

Risk per 10³ person-sachets^a

Change in skin color

Probable

Probable/Likely

0.5

0.3

Red flush

Probable

Certain

0.5

0.3

Diarrhea

Possible

Probable/Likely

0.5

0.3

Tachycardia

Probable

Unlikely

0.5

0.3

Notes:

^aThe number of cases was used as the numerator for the calculation of the risk. The denominators for the calculation of the risks were 1,936 person-days and 3,633 person-sachets.

Hsieh et al. Chinese Medicine 2010 5:6   doi:10.1186/1749-8546-5-6