Table 2.
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