Table 2.
Incidence of any serious adverse events and any kidney-related serious adverse events*
| Adverse events | Type 2 diabetes <5 years | Type 2 diabetes 5–10 years | Type 2 diabetes >10–15 years | Type 2 diabetes >15 years | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CANA | PBO | HR (95% CI) | P value | CANA | PBO | HR (95% CI) | P value | CANA | PBO | HR (95% CI) | P value | CANA | PBO | HR (95% CI) | P value | P interaction | |
| Any SAE (% of subjects) | 242/875 (27.7) | 166/651 (25.5) | 1.03 (0.85, 1.26) | 0.76 | 558/1,838 (30.4) | 472/1,493 (31.6) | 0.85 (0.75, 0.97) | 0.01 | 712/2,308 (30.8) | 599/1,837 (32.6) | 0.85 (0.76, 0.95) | 0.01 | 1,144/2,964 (38.6) | 923/2,554 (36.1) | 0.98 (0.89, 1.07) | 0.59 | 0.08 |
| Any kidney-related SAE† (% of subjects) | 6/875 (0.7) | 5/651 (0.8) | 0.89 (0.27, 2.97) | 0.85 | 24/1,838 (1.3) | 22/1,493 (1.5) | 0.88 (0.49, 0.57) | 0.66 | 23/2,308 (1.0) | 31/1,837 (1.7) | 0.61 (0.36, 1.05) | 0.08 | 54/2,964 (1.8) | 61/2,554 (2.4) | 0.73 (0.50, 1.06) | 0.09 | 0.74 |
CANA, canagliflozin; PBO, placebo; SAE, serious adverse event.
*
Based on the safety population (all trial participants who received the study drug).
†
Kidney-related SAEs based on the Medical Dictionary for Regulatory Activities (MedDRA) terminology, included kidney events (among which are AKI, blood creatinine increase, blood urea increase, eGFR decrease, dialysis, renal impairment) and were defined as life-threatening or led to unplanned hospitalization, prolonged hospitalization, or death (12).