Table 3. Hypocalcemia in the placebo- and active-controlled trials.
| Placebo-Controlled Trials | Active-Controlled Trial | |||
|---|---|---|---|---|
| Placebo (n = 513) n (%) |
Etelcalcetide (n = 503) n (%) |
Cinacalcet (n = 341) n (%) |
Etelcalcetide (n = 338) n (%) |
|
| Hypocalcemia, EOI | 53 (10.3) | 330 (65.6) | 207 (60.7) | 240 (71.0) |
| Hypocalcemia severity | ||||
| Milda | 38 (7.4) | 213 (42.3) | 124 (36.4) | 177 (52.4) |
| Moderatea | 14 (2.7) | 141 (28.0) | 84 (24.6) | 70 (20.7) |
| Severea | 1 (0.2) | 2 (0.4) | 5 (1.5) | 5 (1.5) |
| Life threatening | 0 | 0 | 0 | 0 |
| Unknown | 0 | 0 | 0 | 0 |
| Fatal | 0 | 0 | 0 | 0 |
| Leading to discontinuation of investigational product | 0 | 5 (1.0) | 2 (0.6) | 0 |
| Serious AEs | 0 | 0 | 1 (0.3) | 1 (0.3) |
| Blood calcium decreased | 0 | 0 | 1 (0.3) | 1 (0.3) |
| Number of patients with ≥ 1 postbaseline cCa value | 511 | 499 | 337 | 336 |
| cCa < 7.0 mg/dL | 16 (3.1) | 38 (7.6) | 32 (9.5) | 29 (8.6) |
| cCa < 7.5 mg/dL | 28 (5.5) | 135 (27.1) | 90 (26.7) | 89 (26.5) |
| cCa < 8.3 mg/dL | 99 (19.4) | 392 (78.6) | 245 (72.7) | 278 (82.7) |
AE = adverse event; cCa = albumin-corrected serum calcium; EOI = event of interest.
aMild, moderate, and severe categories as assessed by the investigator.