Tabulated list of adverse reactions: Adverse reactions are listed as follows using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). (See Table 3.)
![](https://mpfshstrg.blob.core.windows.net/mpf-uat-common-resources/Images/monograph/table.gif)
Description of selected adverse reactions: Hypocalcaemia: Most events of asymptomatic blood calcium decreased and symptomatic hypocalcaemia were mild or moderate in severity. In the combined placebo-controlled studies, a higher proportion of patients in the Parsabiv group compared with patients in the placebo group developed at least one serum cCa value < 7.0 mg/dL (1.75 mmol/L) (7.6% Parsabiv; 3.1% placebo), < 7.5 mg/dL (1.88 mmol/L) (27.1% Parsabiv; 5.5% placebo), and < 8.3 mg/dL (2.08 mmol/L) (78.6% Parsabiv; 19.4% placebo). In these studies 1% of patients in the Parsabiv group and 0% of patients in the placebo group discontinued treatment due to the adverse event of low serum calcium. For further information regarding potential manifestations of hypocalcaemia and serum calcium monitoring please see Precautions and Dosage & Administration, respectively.
QTc prolongation secondary to hypocalcaemia: In the combined placebo-controlled studies, a higher percentage of patients in the Parsabiv group compared with the placebo group had a maximum increase from baseline of > 60 msec in the QTcF interval (1.2% Parsabiv; 0% placebo). The patient incidence of maximum post-baseline pre-dialysis QTcF >500 msec in the Parsabiv and placebo groups was 4.8% and 1.9% respectively.
Worsening heart failure: In the combined placebo-controlled studies, the subject incidence of adjudicated CHF events requiring hospitalisation was 2.2% in the Parsabiv treatment group compared to 1.2% in the placebo group.
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