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. 2022 Apr 21;65(7):1085–1097. doi: 10.1007/s00125-022-05694-6

Table 2.

Safety and adverse events of special interest by baseline KDIGO risk categories and subgroups of UACR and eGFR

n/N OR (95% CI) p for interaction
Dapagliflozin Placebo
Discontinuation due to adverse event
 Overall 118/2149 123/2149 0.97 (0.74, 1.26)
 KDIGO risk category
  Moderately high risk 8/330 12/289 0.56 (0.22, 1.38) 0.41
  High risk 31/651 32/696 1.03 (0.62, 1.71)
  Very high risk 79/1168 79/1164 1.03 (0.74, 1.42)
 UACR subgroup
  UACR ≤113.0 55/1102 50/1119 1.12 (0.76, 1.66) 0.48
  UACR >113.0 to ≤395.5 47/881 54/882 0.87 (0.58, 1.30)
  UACR >395.5 16/166 19/148 0.71 (0.35, 1.46)
 eGFR subgroup
  eGFR ≥45 30/879 42/901 0.73 (0.45, 1.19) 0.20
  eGFR ≥30 to <45 60/977 45/917 1.26 (0.84, 1.87)
  eGFR <30 28/293 36/331 0.84 (0.50, 1.43)
Any serious adverse event
 Overall 633/2149 729/2149 0.81 (0.72, 0.93)
 KDIGO risk category
  Moderately high risk 89/330 106/289 0.64 (0.45, 0.90) 0.26
  High risk 176/651 205/696 0.89 (0.70, 1.12)
  Very high risk 368/1168 418/1164 0.83 (0.70, 0.98)
 UACR subgroup
  UACR ≤113.0 284/1102 344/1119 0.78 (0.65, 0.95) 0.79
  UACR >113.0 to ≤395.5 279/881 313/882 0.85 (0.69, 1.03)
  UACR >395.5 70/166 72/148 0.77 (0.49, 1.22)
 eGFR subgroup
  eGFR ≥45 237/879 289/901 0.78 (0.63, 0.96) 0.54
  eGFR ≥30 to <45 295/977 302/917 0.88 (0.72, 1.07)
  eGFR <30 101/293 138/331 0.72 (0.52, 1.00)

Data are based on the safety population of 4298

Cut-off values for UACR are mg/mmol (in mg/g: ≤1000 mg/g, >1000 to ≤3500 mg/g, >3500 mg/g); cut-off values for eGFR are ml min−1 [1.73 m]−2