Table 2.
Parameter | FAS population (n = 65) | PPS population (n = 42) |
---|---|---|
Baseline | ||
Mean ± SD, mg/dL | 6.45 ± 1.698 | 6.31 ± 1.605 |
End of stage 1 | ||
Mean ± SD, mg/dL | 5.90 ± 1.990 | 5.68 ± 2.106 |
Change from BL to end of stage 1 | ||
Mean ± SD | − 0.54 ± 1.508 | − 0.63 ± 1.675 |
Pre-defined modela | ||
LS mean ± SE | − 0.371 ± 0.251 | − 0.433 ± 0.388 |
95% CI | − 0.874, 0.132 | − 1.220, 0.353 |
p valueb | 0.146 | 0.271 |
Post hoc modelc | ||
LS mean ± SE 95% CI p valueb |
− 0.488 ± 0.186 − 0.861, − 0.116 0.011 |
− 0.552 ± 0.270 − 1.098, − 0.005 0.048 |
BL, baseline; CI, confidence interval; FAS, full analysis set; LS, least squares; PPS, per protocol set; SD, standard deviation; SE, standard error
aResults are obtained from a linear mixed model that includes change in serum phosphorus levels from baseline to the end of stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomization, region (non-US/US), and gender as fixed effects (pre-defined statistical model)
bp value for least squares means t test is presented
cResults are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of stage 1 as dependent variable and treatment, baseline serum phosphorus, age at randomization, region (non-US/US), and gender as fixed effects (post hoc analysis)