The following adverse reactions are discussed in greater detail in other sections of labeling: • Hypotension, Worsening Heart Failure and/or Arrhythmias [see Warnings and Precautions (5.3)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis
In three double-blind, placebo-controlled clinical trials, 1,126 patients with CKD on dialysis received study drug (656 cinacalcet, 470 placebo) for up to 6 months. The most frequently reported adverse reactions are listed in Table 1….