Headache 5 (4.7%) 5 (4.4%)
Syncope 3 (2.8%) 1 (0.9%)
Psychiatric Disorders
Depression 3 (2.8%) 0 (0.0%)
Respiratory, Thoracic and Mediastinal Disorders
Cough 3 (2.8%) 2 (1.8%)
Oropharyngeal Pain 4 (3.7%) 0 (0.0%)
Skin and Subcutaneous Tissue Disorders
Pruritus 3 (2.8%) 3 (2.7%)
Rash 4 (3.7%) 1 (0.9%)
Skin Ulcer 3 (2.8%) 0 (0.0%)
Vascular Disorders
Hypertension 7 (6.5%) 4 (3.5%)
Hypotension 5 (4.7%) 3 (2.7%)
a. Includes only events more common in the Zemplar treatment group.
The following adverse reactions, with a causal relationship to Zemplar, occurred in <2% of the Zemplar treated patients in the above double-blind, placebo-controlled clinical trial data set.
Gastrointestinal Disorders: Dry mouth
Investigations: Hepatic enzyme abnormal
Nervous System Disorders: Dysgeusia
Skin and Subcutaneous Tissue Disorders: Urticaria
CKD Stage 5
The safety of Zemplar Capsules has been eva luated in one 12-week, double-blind, placebo-controlled, multicenter clinical study involving 88 CKD Stage 5 patients. Sixty-one patients received Zemplar Capsules and 27 patients received placebo.
The proportion of patients who terminated prematurely from the study due to adverse events was 7% for Zemplar Capsules treated patients and 7% for placebo patients.
Adverse events occurring in the Zemplar Capsules group at a frequency of 2% or greater and more frequently than in the placebo group are as follows:
Table 2. Treatment-Emergent Adverse Events by Body System Occurring in ≥ 2% of Subjects in the Zemplar-Treated Group, Double-Blind, Placebo-Controlled, Phase 3, CKD Stage 5 Study; All Treated Patients Number (%) of Subjects
Adverse Eventsa Zemplar Capsules
(n=61) Placebo
(n = 27)
Overall 43 (70%) 19 (70%)
Gastrointestinal Disorders
Constipation 3 (4.9%) 0 (0.0%)
Diarrhea 7 (11.5%) 3 (11.1%)
Vomiting 4 (6.6%) 0 (0.0%)
General Disorders and Administration Site Conditions
Fatigue 2 (3.3%) 0 (0.0%)
Edema Peripheral 2 (3.3%) 0 (0.0%)
Infections and Infestations
Nasopharyngitis 5 (8.2%) 2 (7.4%)
Peritonitis 3 (4.9%) 0 (0.0%)
Sinusitis 2 (3.3%) 0 (0.0%)
Urinary Tract Infection 2 (3.3%) 0 (0.0%)
Metabolism and Nutrition Disorders
Fluid Overload 3 (4.9%) 0 (0.0%)
Hypoglycemia 2 (3.3%) 0 (0.0%)
Nervous System Disorders
Dizziness 4 (6.6%) 0 (0.0%)
Headache 2 (3.3%) 0 (0.0%)
Psychiatric Disorders &nbs
