Skip to main content
. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774

Table 5. Patient incidence of treatment-emergent gastrointestinal bleeding events with historic control (EVOLVE).

Placebo-Controlled Trials Active-Controlled Trial EVOLVE
(First 6 Months)a
Placebo
(n = 513)
n (%)		 Etelcalcetide
(n = 503)
n (%)		 Cinacalcet
(n = 341)
n (%)		 Etelcalcetide
(n = 338)
n (%)		 Placebo
(n = 1923)
n (%)		 Cinacalcet
(n = 1938)
n (%)
Gastrointestinal hemorrhage (SMQ) 11 (2.1) 10 (2.0) 5 (1.5) 9 (2.7) 36 (1.9) 45 (2.3)

EVOLVE = Evaluation of Cinacalcet Hydrochloride (HCl) Therapy to Lower Cardiovascular Events; SMQ = Standardized Medical Regulatory Dictionary for Regulatory Activities Query.

aPatient incidence rate using GI Hemorrhage SMQ during the first 6 months of the trial; data on file.