Table 3.
Incidence (%) of most frequent adverse drug reactions
| Most frequent adverse events | Placebo-controlled studies
|
Cinacalcet-controlled studies
|
||
|---|---|---|---|---|
| Placebo n=513 | Etelcalcetide n=503 | Cinacalcet n=341 | Etelcalcetide n=338 | |
| Diarrhea | 8.6 | 10.7 | 10.3 | 6.2 |
| Nausea | 6.2 | 10.7 | 22.6 | 18.3 |
| Vomiting | 5.1 | 8.9 | 13.8 | 13.3 |
| Calcium reduction | 10.1 | 63.8 | 59.8 | 68.9 |
| Hypocalcemiaa | 0.2 | 7.0 | 2.3 | 5.0 |
| Hyperkalemia | 3.1 | 4.4 | 5.3 | 3.8 |
| Muscle spasms | 6.6 | 11.5 | 5.9 | 6.5 |
| Paraesthesia | 1.2 | 6.2 | 2.6 | 3.3 |
| Hypotension | – | – | 2.9 | 6.8 |
Note:
a
Hypocalcemia definition: symptomatic reduction in serum corrected calcium <8.3 mg/dL.