Table 1.
SPD405‐404 study: patient disposition and baseline demographic characteristics
| Test group | Concomitant therapy control group | Historical control group | |
|---|---|---|---|
| Enrolled patients, n | 2136 | N/A | N/A |
| Safety analysis set, n (%)† | 2029 (95.0) | N/A | N/A |
| Full analysis set, n (%)‡ | 2027 (94.9) | 8103 | 8112 |
| Transplant recipients, n (%) | 290 (14.3) | 873 (10.8) | 1225 (15.1) |
| Length of follow‐up, months, mean (SD) | 37.5 (21.39) | 37.4 (21.72) | 33.5 (21.58) |
| Length of follow‐up for living patients w/o transplant, n (%)§ | |||
| < 60 months | 3 (0.1) | 5 (0.1) | 3 (< 0.1) |
| 60 months | 718 (35.4) | 2934 (36.2) | 2202 (27.1) |
| Died during the follow‐up period¶, n (%) | 1050 (51.8) | 4372 (54.0) | 4846 (59.7) |
| Transplant recipient during the follow‐up period, n (%) | 290 (14.3) | 873 (10.8) | 1225 (15.1) |
| Age, years, mean (SD) | 57.1 (14.54) | 56.7 (14.58) | 57.1 (14.59) |
| Sex, n (%) | |||
| Male | 1178 (58.1) | 4707 (58.1) | 4714 (58.1) |
| Female | 849 (41.9) | 3396 (41.9) | 3398 (41.9) |
| Race, n (%) | |||
| White | 970 (47.9) | 3940 (48.6) | 4084 (50.3) |
| Non‐white | 1055 (52.0) | 4163 (51.4) | 4025 (49.6) |
| Black/African American | 959 (47.3) | 3529 (43.6) | 3359 (41.4) |
| Asian | 37 (1.8) | 238 (2.9) | 189 (2.3) |
| Other | 59 (2.9) | 396 (4.9) | 477 (5.9) |
| Missing | 2 (0.1) | 0 | 3 (< 0.1) |
| BMI, kg/m2, mean (SD) | 30.31 (8.33) | 29.00 (8.02) | 26.34 (7.14) |
| Serum phosphate, mg/dL, mean (SD) | 5.89 (1.77) | N/A | N/A |
| Presence of diabetes, n (%) | 895 (44.2) | 3920 (48.4) | 2795 (34.5) |
| Duration of ESRD, years, mean (SD) | 5.36 (5.01) | 5.29 (4.96) | 5.47 (4.96) |
Percentages for the safety analysis set and full analysis set are based on enrolled patients. Other percentages are based on the full analysis set.
The safety analysis set comprises all patients who were registered to the study and had previously received lanthanum carbonate treatment for a minimum of 12 consecutive weeks (test group only).
The full analysis set consists of patients in the safety analysis set who also had at least one post‐screening record in the United States Renal Data System database (test group) and their matched control patients (concomitant therapy and historical control groups).
The length of follow‐up for living patients without a transplant is from screening until the date of their last available claim record in the United States Renal Data System database; the length of follow‐up for patients who died or received a transplant is from screening until their death or transplant. The maximum length of follow‐up is 60 months.
Thirty‐four patients (1.7%) in the test group, 81 patients (1.0%) in the concomitant therapy control group and 164 patients (2.0%) in the historical control group had a transplant and died during the follow‐up period.
BMI, body mass index; ESRD, end‐stage renal disease; N/A, not available; SD, standard deviation; w/o, without.