A Phase 3, Randomized Controlled Trial Was Conducted to Evaluate

A phase 3, randomized controlled trial was conducted to evaluate the effect of Drug X and Drug Y on serum parathyroid hormone (PTH) concentrations in patients receiving hemodialysis with severe secondary hyperparathyroidism.  A total of 508 patients were randomly assigned to Drug X or Drug Y after each hemodialysis session for 26 weeks.  The primary efficacy endpoint was the percentage of patients achieving >30% reduction in mean PTH from baseline during weeks 20-27.  A secondary efficacy endpoint was the percentage of patients achieving mean PTH <300 pg/mL.  An excerpt of the study results is as follows: Based on these results, which of the following is a possible 95% confidence interval for the difference in the percentage of patients who achieved the primary efficacy endpoint between Drug X and Drug Y?

A) (−13.9% to −8.9%)
B) (−15.5% to −5.2%)
C) (−19.3% to −12.7%)
D) (−10.2% to 9.7%)
E) (−21.6% to 0.8%)

Correct Answer:

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