Table 1.
Patient Demographics and Clinical Characteristics at Baseline
| Safety and efficacy analysis set N = 13 | |
|---|---|
| Country | |
| Japan | 9 (69.2) |
| Republic of Korea | 4 (30.8) |
| Sex | |
| Female | 7 (53.8) |
| Age (years) | |
| Mean (SD) | 60.5 (10.8) |
| ≥65 | 5 (38.5) |
| Height (cm) | |
| Mean (SD) | 151.45 (10.43) |
| Weight (kg) | |
| Mean (SD) | 61.38 (13.02) |
| Duration of disease, years (n = 12) | |
| Mean (SD) | 10.0 (5.0) |
| Treatment for underlying disease | |
| Inorganic phosphate | 12 (92.3) |
| Active vitamin D3 | 13 (100.0) |
| Calcimimetics | 2 (15.4) |
| Octreotide | 1 (7.7) |
| Radiation | 2 (15.4) |
| Chemotherapy | 0 |
| Other | 0 |
| History of surgery | |
| Yes | 7 (53.8) |
| Tumor identified at baseline | |
| Yes | 7 (53.8) |
| Serum phosphate a (mg/dL) | |
| Mean (SD) | 1.62 (0.49) |
| Corrected serum calcium b (mg/dL) | |
| Mean (SD) | 9.02 (0.33) |
| 1,25‐dihydroxyvitamin D c (pg/mL) | |
| Mean (SD) | 22.58 (11.87) |
| 25‐hydroxyvitamin D d (ng/mL) | |
| Mean (SD) | 26.8 (13.2) |
| Parathyroid hormone, e intact (pg/mL) | |
| Mean (SD) | 112.5 (45.4) |
| Fibroblast growth factor 23, f intact (pg/mL) | |
| Mean (SD) | 1018.8 (1668.8) |
| TmP/GFR, g 2‐hr urinalysis, (mg/dL) | |
| Mean (SD) | 1.1478 (0.4259) |
| Alkaline phosphatase h (U/L) | |
| Mean (SD) | 424.7 (184.8) |
Data are shown as n (%) unless otherwise stated.
LLN = lower limit of normal; SD = standard deviation; TIO = tumor‐induced osteomalacia; TmP/GFR = renal tubular maximum phosphate reabsorption rate/glomerular filtration rate; ULN = upper limit of normal.
Normal range according to the central laboratory 2.4–4.3 mg/dL (the value at baseline was below the LLN in 12/13 patients [92.3%]).
Normal range according to the central laboratory 8.5–10.2 mg/dL (the value at baseline was below the LLN in 1/13 patients [7.7%]).
Normal range according to the central laboratory 20–60 pg/mL (the value at baseline was below the LLN in 7/13 patients [53.8%]).
Normal range according to Fukumoto et al.( 27 ) ≥20 ng/mL (the value at baseline was below the LLN in 3/13 patients [23.1%]).
Normal range according to the central laboratory 10–65 pg/mL (the value at baseline was above the ULN in 11/13 patients [84.6%]).
Normal range according to Fukumoto et al.( 27 ) ≥30 pg/mL (the value at baseline was above the ULN in 13/13 patients [100%]).
Normal ranges according to Chong et al.( 7 ) are age‐ and sex‐dependent (the value at baseline was below the LLN in 13/13 patients [100%]).
Normal range according to the central laboratory 115–359 U/L (the value at baseline was above the ULN in 6/13 patients [46.2%]).