Table 5

Adverse Events

PlaceboNesiritidep Value
(n = 138)(n = 141)
n (%)n (%)
Overall summary
 Any event123 (89.1)132 (93.6)0.205
 Any event classified as related to study drug27 (19.6)32 (22.7)0.560
 Any serious event51 (37.0)43 (30.5)0.258
 Any serious event classified as related to study drug6 (4.3)2 (1.4)0.170
 Any event causing withdrawal from the study5 (3.6)5 (3.5)1.000
Cardiac, renal, and pulmonary adverse events occurring in ≥5% of patients
 Hypotension43 (31.2)36 (25.5)0.352
 Atrial fibrillation44 (31.9)30 (21.3)0.057
 Pleural effusion31 (22.5)30 (21.3)0.885
 Atelectasis28 (20.3)24 (17.0)0.540
 Peripheral edema15 (10.9)13 (9.2)0.694
 Acute renal failure17 (12.3)10 (7.1)0.160
 Ventricular tachycardia11 (8.0)14 (9.9)0.676
 Respiratory failure16 (11.6)3 (2.1)0.002
 Sinus tachycardia11 (8.0)7 (5.0)0.339
 Dyspnea7 (5.1)9 (6.4)0.798
  • Based on investigator classification without a predetermined requirement for dialysis.