Table 3.

Summary of adverse events (safety analysis set)

AENo. (%) of Patients
SZC, n=97PBO, n=99
Any AE40 (41.7)46 (46.5)
Any serious AEa7 (7.3)8 (8.1)
AE leading to discontinuation of treatment4 (4.2)2 (2.0)
Death1 (1.0)0 (0.0)
AEs in >2% patients
 Constipation4 (4.2)3 (3.0)
 Diarrhea4 (4.2)6 (6.1)
 Headache3 (3.1)2 (2.0)
 Nasopharyngitis3 (3.1)5 (5.1)
 Hyperkalemia2 (2.1)6 (6.1)
 Hordeolum (stye)2 (2.1)0 (0.0)
 Muscle spasms2 (2.1)2 (2.0)
 Dizziness1 (1.0)4 (4.0)
 Dyspnea1 (1.0)3 (3.0)
 Pruritus1 (1.0)3 (3.0)
 Shunt stenosis1 (1.0)3 (3.0)
  • AE, adverse event; SZC, sodium zirconium cyclosilicate; PBO, placebo.

  • a Including events with death as the outcome.