Table 3.
Treatment-emergent adverse events
| Adverse events | Etelcalcetide (n = 82) |
Control (n = 42) | |
|---|---|---|---|
| Etelcalcetide + Vit D (n = 41) | Etelcalcetide + Ca (n = 41) | ||
| Blood calcium decreasea | 29 (70.7%) | 32 (82.1%) | 5 (12.2%) |
| Severe blood Ca decreaseb | 0 (0.0%) | 5 (12.2%) | 0 (0.0%) |
| AVF-site complication | 2 (4.9%) | 4 (9.8%) | 3 (7.1%) |
| Infection | 1 (2.4%) | 4 (9.8%) | 0 (0.0%) |
| CVD/heart failure | 1 (2.4%) | 4 (9.8%) | 2 (4.8%) |
| Cancer | 0 (0.0%) | 2 (4.9%) | 0 (0.0%) |
| Fracture | 0 (0.0%) | 0 (0.0%) | 1 (2.4%) |
| Joint pain | 1 (2.4%) | 1 (2.4%) | 0 (0.0%) |
| Rash | 0 (0.0%) | 1 (2.4%) | 0 (0.0%) |
| Nausea | 1 (2.4%) | 0 (0.0%) | 0 (0.0%) |
AVF, arteriovenous fistula; CVD, cardiovascular disease; E+Ca, etelcalcetide + oral calcium preparation; E+D, etelcalcetide + active vitamin D; Vit D, vitamin D.
Data expressed as number (%).
a
Blood calcium decrease defined as a corrected Ca level of < 8.3 mg/dL (need medical intervention: add/increase active Vit D or oral calcium preparations according to allocation).
b
Severe blood Ca decrease defined as a corrected Ca level of < 7.4 mg/dL (stop etelcalcetide).