Table 4:
Number of participants with adverse events according to the Medical Dictionary for Regulatory Activities System Order Class version 23.1 and number of deaths in the VitaVasK study.
| Event | Controls (n = 32) | Vitamin K1 (n = 30) |
|---|---|---|
| Any adverse event | 91 | 55 |
| Any serious adverse event | 64 | 53 |
| DeathsDeath from cardiovascular cause within 18 months after start of treatment | 31 | 40 |
| Blood and lymphatic | 2 | 1 |
| Myocardial infarctionAcute coronary syndromeOther cardiaca | 3213 | 124 |
| Congenital and genetic | 0 | 0 |
| Ear and labyrinth | 0 | 0 |
| Endocrine | 1 | 1 |
| Eye | 2 | 2 |
| Gastrointestinal | 10 | 14 |
| General | 14 | 7 |
| Hepatobiliary | 1 | 1 |
| Immune system | 0 | 0 |
| Infections and infestations | 10 | 8 |
| Injury, poisoning and procedural complications | 8 | 2 |
| Investigations | 8 | 5 |
| Metabolism and nutrition | 0 | 0 |
| Musculoskeletal | 9 | 6 |
| Neoplasms | 0 | 3 |
| Nervous systemStroke | 61 | 21 |
| Pregnancy | 0 | 0 |
| Product issues | 0 | 0 |
| Psychiatric | 3 | 1 |
| Renal and urinary | 0 | 0 |
| Reproductive and breast | 0 | 0 |
| Respiratory | 11 | 14 |
| Skin | 2 | 1 |
| Social | 0 | 0 |
| Surgical/medical procedures | 17 | 18 |
| EmbolismSymptoms-driven revascularizationAV fistula thrombosisOther vascular | 002010 | 0163 |
a
Arrhythmia, hypertensive crisis, hypotension, stable angina pectoris.