Table 3.
Vital signs for the maintenance-phase safety population
| Vital Sign | Mean (95% CI) Value at CP Baseline, n=746 | Mean (95% CI) Change from CP Baselinea | |
|---|---|---|---|
| Day 29, n=701 | Day 365/EOS, n=731b | ||
| Systolic BP, mm Hg | 135.6 (134.2 to 137.0) | −1.1 (–2.4 to 0.2) | 0.0 (–1.4 to 1.4) |
| Diastolic BP, mm Hg | 77.1 (76.3 to 77.8) | −0.3 (–1.0 to 0.4) | −0.6 (–1.4 to 0.2) |
| Pulse rate, beats per minute | 69.0 (68.2 to 69.8) | 0.1 (–0.6 to 0.7) | 1.3 (0.5 to 2.0) |
| Weight, kgc | 86.25 (84.66 to 87.84) | 0.28 (–0.06 to 0.62) | 0.32 (–0.10 to 0.74) |
95% CI, 95% confidence interval; CP, correction phase; EOS, end of study.
a
The safety population comprised all participants who received one or more doses of sodium zirconium cyclosilicate during the given study phase and had any postbaseline follow-up for safety.
b
Day 365/EOS represents the last scheduled study visit day (±1 day) while on study drug.
c
The numbers of participants with available weight measure were 743, 690, and 426 for CP baseline and days 29 and 365/EOS of the maintenance phase, respectively.