Table 4. Patient incidence of treatment-emergent adverse events of interest.
| Placebo-Controlled Trials | Active-Controlled Trial | Open-Label Extension Trials | |||
|---|---|---|---|---|---|
| Placebo (n = 513) n (%) |
Etelcalcetide (n = 503) n (%) |
Cinacalcet (n = 341) n (%) |
Etelcalcetide (n = 338) n (%) |
Etelcalcetide (n = 1298) n (%) |
|
| Adverse events of interest | |||||
| Hypocalcemia | 53 (10.3) | 330 (65.6) | 207 (60.7) | 240 (71.0) | 586 (45.1) |
| Blood calcium decreased | 52 (10.1) | 321 (63.8) | 204 (59.8) | 233 (68.9) | 565 (43.5) |
| Hypocalcemia | 1 (0.2) | 35 (7.0) | 8 (2.3) | 17 (5.0) | 37 (2.9) |
| Adjusted calcium decreased | 0 | 0 | 0 | 2 (0.6) | 12 (0.9) |
| Chvostek’s sign | 0 | 0 | 1 (0.3) | 0 | — |
| Hypophosphatemia events | 2 (0.4) | 7 (1.4) | 3 (0.9) | 5 (1.5) | 32 (2.5) |
| Hypophosphatemia | 1 (0.2) | 7 (1.4) | 3 (0.9) | 2 (0.6) | 26 (2.0) |
| Blood phosphorus decreased | 1 (0.2) | 0 | 0 | 3 (0.9) | 6 (0.5) |
| Ventricular tachyarrhythmias | 4 (0.8) | 2 (0.4) | 0 | 0 | 13 (1.0) |
| Ventricular tachycardia | 0 | 2 (0.4) | 0 | 0 | 2 (0.2) |
| Ventricular extrasystoles | 2 (0.4) | 0 | 0 | 0 | 3 (0.3) |
| Ventricular fibrillation | 1 (0.2) | 0 | 0 | 0 | 7 (0.5) |
| Ventricular tachyarrhythmia | 1 (0.2) | 0 | 0 | 0 | 0 |
| Convulsions | 5 (1.0) | 4 (0.8) | 2 (0.6) | 3 (0.9) | 21 (1.6) |
| Hypersensitivity | 19 (3.7) | 22 (4.4) | 17 (5.0) | 19 (5.6) | 83 (6.4) |
| Infusion reactiona | 29 (5.7) | 29 (5.8) | 16 (4.7) | 23 (6.8) | 110 (8.5) |
AE = adverse event; cCa = albumin-corrected serum calcium; EOI = event of interest.
aInfusion reaction as listed in the Infusion Reaction EOI (narrow search) with onset day coinciding with investigational product infusion which were resolved on the same day or the day after onset.