Table 5.
Number of participants with adverse events by the Medical Dictionary for Regulatory Activities System Order Class, number of deaths, and participants who commenced RRT
| Event | n (%) | |
|---|---|---|
| Vitamin K (n=95)a | Placebo (n=94) | |
| Any event | 69 (72) | 68 (72) |
| Blood and lymphatic | 3 (3) | 4 (4) |
| Cardiac | 5 (5) | 4 (4) |
| Congenital and genetic | 1 (1) | 0 (0) |
| Ear and labyrinth | 0 (0) | 1 (1) |
| Endocrine | 0 (0) | 1 (1) |
| Eye | 0 (0) | 1 (1) |
| Gastrointestinal | 13 (14) | 12 (13) |
| General | 2 (2) | 1 (1) |
| Hepatobiliary | 1 (1) | 3 (3) |
| Immune system | 0 (0) | 1 (1) |
| Infections and infestations | 29 (31) | 30 (32) |
| Injury, poisoning and procedural complications | 19 (20) | 14 (15) |
| Investigations | 3 (3) | 9 (10) |
| Metabolism and nutrition | 9 (9) | 4 (4) |
| Musculoskeletal | 8 (8) | 13 (14) |
| Neoplasms | 2 (2) | 1 (1) |
| Nervous system | 5 (5) | 10 (11) |
| Psychiatric | 0 (0) | 2 (2) |
| Renal and urinary | 9 (9) | 6 (6) |
| Reproductive and breast | 0 (0) | 1 (1) |
| Respiratory | 4 (4) | 6 (6) |
| Skin | 11 (12) | 4 (4) |
| Surgical/medical procedures | 11 (12) | 9 (10) |
| Vascular | 3 (3) | 3 (3) |
| Deaths | 2 (3) | 1 (1) |
| Commenced RRTb | 1 (1) | 1 (1) |
a
All 189 randomized individuals included in adverse event analysis.
b
Haemodialysis, peritoneal dialysis, or renal transplant.