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. 2016 Nov 11;21(12):987–994. doi: 10.1111/nep.12864

Table 2.

SPD405‐404 study: rates of bone fracture requiring hospitalisation based on United States Renal Data System data from 2014 (Full analysis set)

Test group (N = 2027) Concomitant therapy control group (N = 8103) Historical control group (N = 8112)
n (%) n (%) n (%)
120 (5.9) 546 (6.7) 519 (6.4)

The full analysis set comprises patients in the safety analysis set who also had at least one post‐screening record in the United States Renal Data System database (test group) and their matched control patients (concomitant therapy and historical control groups).