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Table 2 Reporting of patient-reported outcome in prescribing information labeling versus medical review documents

From: Patient-reported outcomes in breast cancer FDA drug labels and review documents

 

N (%)

Original labeling

0 / 13 (0%)

Most recent labeling

0 / 11a (0%)

Medical Review documents

11 / 13 (85%)

  1. aOriginal prescribing information labeling of two drugs (Piqray, Enhertu) were the latest versions