p; Uremia 7 (7%) 9 (8%)
Gout 4 (4%) 6 (5%)
Dehydration 3 (3%) 1 (1%)
Acidosis 2 (2%) 1 (1%)
Hyperkalemia 2 (2%) 3 (3%)
Hyperphosphatemia 2 (2%) 4 (4%)
Hypoglycemia 2 (2%) 4 (4%)
Hypokalemia 2 (2%) 1 (1%)
Musculoskeletal 12 (11%) 9 (8%)
Arthritis 5 (5%) 1 (1%)
Leg Cramps 3 (3%) 0 (0%)
Myalgia 2 (2%) 5 (4%)
Nervous 18 (17%) 12 (11%)
Dizziness 5 (5%) 5 (4%)
Vertigo 5 (5%) 0 (0%)
Depression 3 (3%) 0 (0%)
Insomnia 2 (2%) 2 (2%)
Neuropathy 2 (2%) 1 (1%)
Respiratory 26 (24%) 25 (22%)
Pharyngitis 11 (10%) 12 (11%)
Rhinitis 5 (5%) 4 (4%)
Bronchitis 3 (3%) 1 (1%)
Cough Increased 3 (3%) 2 (2%)
Sinusitis 3 (3%) 1 (1%)
Epistaxis 2 (2%) 1 (1%)
Pneumonia 2 (2%) 0 (0%)
Skin and Appendages 17 (16%) 10 (9%)
Rash 6 (6%) 3 (3%)
Pruritus 3 (3%) 3 (3%)
Skin Ulcer 3 (3%) 0 (0%)
Skin Hypertrophy 2 (2%) 0 (0%)
Vesiculobullous Rash 2 (2%) 1 (1%)
Special Senses 9 (8%) 11 (10%)
Amblyopia 2 (2%) 0 (0%)
Retinal Disorder 2 (2%) 0 (0%)
Urogenital System 10 (9%) 10 (9%)
Urinary Tract Infection 3 (3%) 1 (1%)
Kidney Function Abnormal 2 (2%) 1 (1%)
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 4. 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
Body Systema
COSTART V Term Zemplar Capsules
(n=61) Placebo
(n = 27)
a. Includes all patients with events in that body system.
Overall 43 (70%) 19 (70%)
Body as a Whole 27 (44%) 8 (30%)
Infection 9 (15%) 3 (11%)
Asthenia 3 (5%) 0 (0%)
Peritonitis 3 (5%) 0 (0%)
Accidental Injury 2 (3%) 0 (0%)
Headache 2 (3%) 0 (0%)
Digestive 18 (30%) 4 (15%)
Diarrhea 7 (11%) 3 (11%)
Constipation 3 (5%) 0 (0%)
Nausea and Vomiting 3 (5%) 0 (0%)
Dyspepsia 2 (3%) 0 (0%)
Hemic and Lymphatic System 6 (10%) 0 (0%)
Hypervolemia 3 (5%) 0 (0%)
Ecchymosis 2 (3%) 0 (0%)
Metabolic and Nutritional Disorders 7 (11%) 0 (0%)
Hypoglycemia 2 (3%) 0 (0%)
Peripheral Edema 2 (3%) 0 (0%)
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