Table 3.
Parameter | Age ≥ 2 to < 6 years (n = 6) | Age ≥ 6 to < 12 years (n = 17) | Age ≥ 12 to ≤ 18 years (n = 42) |
---|---|---|---|
Baseline | |||
Mean ± SD, mg/dL | 7.33 ± 1.992 | 6.93 ± 1.883 | 6.12 ± 1.522 |
End of stage 1 | |||
Mean ± SD, mg/dL | 7.09 ± 1.924 | 6.21 ± 2.730 | 5.61 ± 1.578 |
Change from BL to stage 1 | |||
Mean ± SD | − 0.24 ± 0.783 | − 0.72 ± 2.136 | − 0.51 ± 1.291 |
Pre-defined modela | |||
LS mean ± SE | − 0.243 ± 0.380 | − 0.620 ± 0.489 | − 0.460 ± 0.192 |
95% CI | − 1.450, 0.965 | − 1.675, 0.436 | − 0.850, − 0.070 |
p valueb | 0.568 | 0.227 | 0.022 |
Post hoc modelc | |||
LS mean ± SE 95% CI p valueb |
− 0.243 ± 0.405 − 1.986, 1.501 0.610 |
− 0.608 ± 0.498 − 1.694, 0.478 0.246 |
− 0.460 ± 0.195 − 0.856, − 0.065 0.024 |
BL, baseline; CI, confidence interval; FAS, full analysis set; LS, least squares; 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)