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. Author manuscript; available in PMC: 2024 Mar 15.
Published in final edited form as: Clin Cancer Res. 2023 Sep 15;29(18):3573–3578. doi: 10.1158/1078-0432.CCR-23-0459

Table 1: Baseline Demographics and Disease Characteristics in the Efficacy and Safety Populations of Study LIBRETTO-001.

Efficacy Population N = 41 Safety Population N = 796
Sex, n (%)
 Female 22 (54) 390 (49)
 Male 19 (46) 406 (51)
Age at diagnosis (years), median [range] 50 [21, 85] 59 [15, 92]
Race, n (%)
 Asian 10 (24) 185 (23)
 Black or African American 2 (5) 25 (3)
 White 28 (68) 545 (69)
Ethnicity, n (%)
 Hispanic or Latino 3 (7) 40 (5)
 Not Hispanic or Latino 37 (90) 737 (93)
Region, n (%)
 Asia 12 (29) 185 (23)
 Europe 3 (7) 123 (15)
 North America 26 (63) 473 (59)
ECOG performance status at study entry, n (%)
 0 14 (34) 294 (37)
 1 25 (61) 464 (58)
History of Metastatic Disease
 Yes 95% 98%
Number of Prior Lines of Therapy, median [range] 2 [0, 9] 1 [0, 15]

ECOG = Eastern Cooperative Oncology Group

Source: U.S. Food and Drug Administration. sNDA Multi-disciplinary Review and Evaluation and Approval Package: RETEVMO (selpercatinib).19