Table 5.

Frequency of adverse events relating to fluid overload as reported by the clinical investigators on adverse event forms (not adjudicated)

Signs of Fluid Overload (n [%])Avosentan 25 mg (n = 455)Avosentan 50 mg (n = 478)Placebo (n = 459)P
Avosentan 25 mg versus PlaceboAvosentan 50 mg versus Placebo
Peripheral edema78 (17.1)80 (16.7)77 (16.7)0.7060.822
Other edema42 (9.2)55 (11.5)25 (5.4)0.0530.006
Fluid overload28 (6.2)26 (5.4)5 (1.1)<0.0010.001
Dyspnea31 (6.8)34 (7.1)15 (3.3)0.0520.197
Acute pulmonary edema9 (2.0)8 (1.7)4 (0.9)0.2860.184
CHF27 (5.9)18 (3.8)10 (2.2)0.0030.107
  • See also Table 2 for CHF as adjudicated secondary outcome, not included here. Symptoms of fluid overload were taken from the reports of adverse and serious adverse events of the investigative centers. The frequency of those symptoms was not different between participants below/above the median of baseline eGFR.