TABLE 4

Reported AE Cases per 1 Million Units Sold (ie, Tablets, Gelatin Capsules, Liquid Equivalents) by Exposure Type

Case TypeTotal Pediatric AE Cases (n = 3251)Total Rate of Pediatric AE Cases per 1 Million Units Sold (95% CI)Single Pediatric AE Case per Units Sold
All cases32510.573 (0.553–0.593)1 case per 1.75 million units sold
AUI cases21830.385 (0.369–0.401)1 case per 2.60 million units sold
Medication error cases4230.075 (0.068–0.082)1 case per 13.33 million units sold