Table 4.
Adverse events, potentially clinically significant laboratory values, and discontinuations related to adverse events or laboratory abnormalities by CKD stage and treatment group
| Variable | CKD Stage 1 (n=502) | CKD Stage 2 (n=689) | CKD Stage 3 (n=248) | |||
|---|---|---|---|---|---|---|
| Tolvaptan (n=330) | Placebo (n=172) | Tolvaptan (n=465) | Placebo (n=224) | Tolvaptan (n=163) | Placebo (n=85) | |
| AEs (% of patients with at least one event) | ||||||
| Thirst | 53.6 | 20.9 | 57.2 | 19.2 | 53.4 | 23.5 |
| Polyuria | 44.8 | 18.6 | 35.5 | 16.5 | 33.7 | 16.5 |
| Nocturia | 28.5 | 12.2 | 29.5 | 12.9 | 30.1 | 15.3 |
| Pollakiuria | 16.1 | 6.4 | 27.5 | 5.4 | 25.2 | 2.4 |
| Kidney pain | 27.9 | 37.2 | 27.7 | 32.1 | 30.7 | 44.7 |
| Hematuria | 7.2 | 14.5 | 8.0 | 12.4 | 10.4 | 17.6 |
| UTI | 9.4 | 14.0 | 12.3 | 14.2 | 4.3 | 12.9 |
| Potentially clinically significant laboratory values (% of patients with at least one value) | ||||||
| Serum sodium >150 mEq/L, % | 2.4 | 2.9 | 4.1 | 1.3 | 6.7 | 0 |
| Serum uric acid >7.5 mg/dl, % | 20.7 | 12.9 | 38.7 | 24.7 | 71.8 | 49.4 |
| Serum ALT >2.5 times ULN | 5.2 (2.18)a | 1.7 (0.66)a | 5.6 (2.21)a | 1.3 (0.48)a | 7.4 (2.87)a | 2.4 (0.82)a |
| Serum AST >2.5 times ULN | 3.9 (1.66)a | 0.6 (0.22)a | 3.7 (1.45)a | 0.9 (0.32)a | 4.9 (1.91)a | 1.2 (0.41)a |
| Serum bilirubin >2 times ULN | 0.3 (0.13)a | 0 (0)a | 0.2 (0.09)a | 1.3 (0.48)a | 0.6 (0.24)a | 0 (0)a |
| Discontinuations related to AEs or laboratory abnormalities (% of patients) | ||||||
| All AEs | 17.0 | 5.8 | 14.6 | 4.9 | 14.7 | 3.5 |
| Liver-related AEs or laboratory abnormalities | 1.5 | 2.9 | 1.5 | 0.9 | 1.8 | 1.2 |
AE, adverse events; UTI, urinary tract infection; ALT, alanine aminotransferase; ULN, upper limit of normal; AST, aspartate aminotransferase.
a
Events per 100 person years.