Chapter 7 132 Table 3: Descriptive statistics of expanded access publications included in this review. Publication Collaboration Variable Overall, N = 1,2311 International, N = 1491 National, N = 1,0821 Number of patients included in report Mean (SD) 413 (3,161) 881 (1,743) 348 (3,304) Median (25%; 75%) 43 (8; 149) 239 (37; 1,032) 37 (6; 113) Minimum; Maximum 1; 95,000 3; 14,204 1; 95,000 Case report No, N>1 1,077 (88%) 149 (100%) 928 (86%) Yes, N=1 152 (12%) 0 (0%) 152 (14%) Single- or multicenter Multicenter 702 (57%) 149 (100%) 553 (51%) Single center 479 (39%) 0 (0%) 479 (44%) Not described 50 (4.1%) 0 (0%) 50 (4.6%) Methodology Retrospective 626 (51%) 51 (34%) 575 (53%) Prospective 495 (40%) 81 (54%) 414 (38%) Not described 110 (8.9%) 17 (11%) 93 (8.6%) Includes pediatric patients No 892 (72%) 97 (65%) 795 (73%) Yes 266 (22%) 47 (32%) 219 (20%) Not described 73 (5.9%) 5 (3.4%) 68 (6.3%) 1n (%). SD, standard deviation. 0 1 2 - 3 4 - 9 10 - 21 22 - 240 Number of publications by quintile Figure 9: Global distribution of number of peer-reviewed expanded access publications, by quintile.
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