TABLE 5

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

Product TypeTotal Reported AE Rate per 1 Million Units Sold (95% CI)Single Pediatric AE Case per Units SoldReported AUI AE Rate per 1 Million Units Sold (95% CI)Single AUI AE Case per Units SoldReported Medication Error AE Rate per 1 Million Units Sold (95% CI)Single Medication Error AE Case per Units Sold
Liquid4.363 (4.182–4.550)1 case per 0.23 million units sold3.012 (2.862–3.168)1 case per 0.33 million units sold0.678 (0.608–0.754)1 case per 1.47 million units sold
Solid0.203 (0.191–0.216)1 case per 4.93 million units sold0.130 (0.120–0.140)1 case per 7.69 million units sold0.016 (0.013–0.020)1 case per 62.5 million units sold
Pediatric1.189 (1.142–1.237)1 case per 0.84 million units sold0.820 (0.781–0.860)1 case per 1.21 million units sold0.164 (0.147–0.182)1 case per 6.10 million units sold
Adult0.139 (0.127–0.152)1 case per 7.19 million units sold0.093 (0.083–0.103)1 case per 10.75 million units sold0.009 (0.007–0.013)1 case per 111.11 million units sold
Single-ingredient product1.023 (0.984–1.064)1 case per 0.98 million units sold0.723 (0.690–0.758)1 case per 1.38 million units sold0.128 (0.114–0.142)1 case per 7.81 million units sold
Fixed-combination product0.236 (0.219–0.253)1 case per 4.24 million units sold0.129 (0.116–0.142)1 case per 7.75 million units sold0.038 (0.032–0.045)1 case per 26.32 million units sold