Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union

Table 2 PRO claim types granted by the FDA or the EMA

Type of claim	FDA-granted claim (N = 5 products)	EMA-granted claim (N = 5 products)	Total claims (N = 5 products)
Symptom: pain	2	4	6
Prostate cancer–specific HRQOL	0	2	2
Generic HRQOL	0	1	1
Total claims	2	7	9

EMA = European Medicines Agency; FDA = Food and Drug Administration; HRQOL = health-related quality of life.

ISSN: 1477-7525