Table 3 Adverse events by MedDRA System Order Class (SOC)
|  | Bicarbonate (n = 152) | Placebo (n = 148) |
|---|---|---|
Number of adverse events per participant (%) | ||
 0 | 21 (13.8) | 16 (10.8) |
 1 | 23 (15.1) | 41 (27.7) |
 2 | 27 (17.8) | 35 (23.6) |
 3 | 35 (23.0) | 15 (10.1) |
 4 or more | 46 (30.3) | 41 (27.7) |
Total number of adverse events | 457 | 400 |
SOC classification—number of events | ||
 Blood and lymphatic system disorders | 5 | 1 |
 Cardiac disorders | 32 | 19 |
 Congenital, familial and genetic disorders | 0 | 1 |
 Ear and labyrinth disorders | 1 | 1 |
 Endocrine disorders | 1 | 2 |
 Eye disorders | 6 | 6 |
 Gastrointestinal disorders | 45 | 25 |
 General disorders and administration site conditions | 14 | 20 |
 Hepatobiliary disorders | 0 | 0 |
 Immune system disorders | 0 | 0 |
 Infections and infestations | 113 | 118 |
 Injury, poisoning and procedural complications | 41 | 32 |
 Investigations | 5 | 7 |
 Metabolism and nutrition disorders | 19 | 27 |
 Musculoskeletal and connective tissue disorders | 28 | 17 |
 Neoplasms benign, malignant and unspecified (including cysts and polyps) | 9 | 16 |
 Nervous system disorders | 24 | 12 |
 Psychiatric disorders | 1 | 5 |
 Renal and urinary disorders | 23 | 23 |
 Reproductive system and breast disorders | 4 | 1 |
 Respiratory, thoracic and mediastinal disorders | 26 | 14 |
 Skin and subcutaneous tissue disorders | 16 | 11 |
 Surgical and medical procedures | 34 | 30 |
 Vascular disorders | 10 | 12 |