Table 4.

Adverse events, potentially clinically significant laboratory values, and discontinuations related to adverse events or laboratory abnormalities by CKD stage and treatment group

VariableCKD 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)
 Thirst53.620.957.219.253.423.5
 Polyuria44.818.635.516.533.716.5
 Nocturia28.512.229.512.930.115.3
 Pollakiuria16.16.427.55.425.22.4
 Kidney pain27.937.227.732.130.744.7
 Hematuria7.214.58.012.410.417.6
 UTI9.414.012.314.24.312.9
Potentially clinically significant laboratory values (% of patients with at least one value)
 Serum sodium >150 mEq/L, %2.42.94.11.36.70
 Serum uric acid >7.5 mg/dl, %20.712.938.724.771.849.4
 Serum ALT >2.5 times ULN5.2 (2.18)a1.7 (0.66)a5.6 (2.21)a1.3 (0.48)a7.4 (2.87)a2.4 (0.82)a
 Serum AST >2.5 times ULN3.9 (1.66)a0.6 (0.22)a3.7 (1.45)a0.9 (0.32)a4.9 (1.91)a1.2 (0.41)a
 Serum bilirubin >2 times ULN0.3 (0.13)a0 (0)a0.2 (0.09)a1.3 (0.48)a0.6 (0.24)a0 (0)a
Discontinuations related to AEs or laboratory abnormalities (% of patients)
 All AEs 17.05.814.64.914.73.5
 Liver-related AEs or laboratory abnormalities1.52.91.50.91.81.2
  • AE, adverse events; UTI, urinary tract infection; ALT, alanine aminotransferase; ULN, upper limit of normal; AST, aspartate aminotransferase.

  • a Events per 100 person years.