Table 2 Comparison of enrollment and demographics reported in FDA premarket approval summaries with corresponding publications and those published studies. Figures are numbers (percentage) unless stated otherwise

	All studies (n=86)	Pivotal studies* (n=66)
Discrepancy in enrollment	22 (26)	18 (27)
Discrepancy >5%	14 (16)	11 (17)
Discrepancy <5%	8 (9)	7 (11)
Mean (range) difference in No of patients enrolled (range)	−1.4 (−104-181)	−1.1 (−104-181)
Mean (range) % difference in No of patients enrolled	−1.2 (−39-39)	−0.7 (−39-39)
Absolute difference in No of patients enrolled (range)	12.8 (0-181)	16.7 (0-181)
Absolute mean difference in % enrolled (range)	4 (0-39)	4 (0-39)
Discrepancy in mean age	9 (11)	8 (12)
Discrepancy in % male	14 (16)	12 (18)

*Study was classified as pivotal if it was only one included in summary, multicenter randomized controlled trial, or explicitly noted in summary as being pivotal study.