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Table 3 Adverse events by MedDRA System Order Class (SOC)

From: Clinical and cost-effectiveness of oral sodium bicarbonate therapy for older patients with chronic kidney disease and low-grade acidosis (BiCARB): a pragmatic randomised, double-blind, placebo-controlled trial

 Bicarbonate (n = 152)Placebo (n = 148)
Number of adverse events per participant (%)
 021 (13.8)16 (10.8)
 123 (15.1)41 (27.7)
 227 (17.8)35 (23.6)
 335 (23.0)15 (10.1)
 4 or more46 (30.3)41 (27.7)
Total number of adverse events457400
SOC classification—number of events
 Blood and lymphatic system disorders51
 Cardiac disorders3219
 Congenital, familial and genetic disorders01
 Ear and labyrinth disorders11
 Endocrine disorders12
 Eye disorders66
 Gastrointestinal disorders4525
 General disorders and administration site conditions1420
 Hepatobiliary disorders00
 Immune system disorders00
 Infections and infestations113118
 Injury, poisoning and procedural complications4132
 Metabolism and nutrition disorders1927
 Musculoskeletal and connective tissue disorders2817
 Neoplasms benign, malignant and unspecified (including cysts and polyps)916
 Nervous system disorders2412
 Psychiatric disorders15
 Renal and urinary disorders2323
 Reproductive system and breast disorders41
 Respiratory, thoracic and mediastinal disorders2614
 Skin and subcutaneous tissue disorders1611
 Surgical and medical procedures3430
 Vascular disorders1012