Skip to main content

Table 1 Summary of number of harms by document

From: Usability and consistency of harm information in drug product descriptions: a matched comparison of data between the United States (US) and Europe

 

Median # harms reported (range)

Median # harms reported only in one document(range)

Median # median # of the same harms reported by both documents (range)

SmPC

114

(56, 265)

43

(20, 181)

75

(36, 104)

USPI

200

(65, 425)

168

(38, 336)

 Â