TO PARSABIV® in
the clinical trials
Adverse reactions reported in ≥ 5% of
Parsabiv® (etelcalcetide)-treated patients1
Combined placebo-controlled substances
N = 503
N = 513
|Blood calcium decreased†||64||10|
*Included adverse reactions reported with at least 1% greater incidence in the Parsabiv® group compared to the placebo group.
†Asymptomatic reductions in calcium below 7.5 mg/dL or clinically significant asymptomatic reductions in corrected serum calcium between 7.5 and < 8.3 mg/dL (that required medical management).
‡Symptomatic reductions in corrected serum calcium < 8.3 mg/dL.
§Paresthesia includes preferred terms of paresthesia and hypoesthesia.
- Overall, in placebo-controlled studies, 1.8% of patients in the Parsabiv® (etelcalcetide) group and 2.5% of patients in the placebo group discontinued treatment due to an adverse event2
Low serum calcium
- Most events of blood calcium decrease or hypocalcemia were mild or moderate in severity in both the placebo and Parsabiv® groups2,3
- In combined placebo-controlled studies, 1% of patients who received Parsabiv® discontinued treatment due to low corrected serum calcium vs 0% with placebo1
Treatment-emergent adverse events experienced by ≥ 5% of Parsabiv®- or Sensipar® (oral cinacalcet)-treated patients4,5
Head-to-head study (active-controlled)
n = 338
n = 341
|Blood calcium decreased†||69||60|
|Pain in extremity||5||4|
* The term treatment emergent refers to a condition either not present before exposure to a study drug that develops after drug exposure or a condition present before exposure that worsens in frequency or severity. Adverse events occurring after the first dose of study drug and up to 30 days after the last dose of study drug were included. Counts and proportions refer to patients rather than to adverse events. In other words, patients may have one or more adverse event.
†Defined as an albumin-corrected serum calcium concentration lower than 8.3 mg/dL (to convert to mmol/L, multiply by 0.25) that resulted in a medical intervention.
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