Table 4.
Adverse events in the KD and control groups over 6 months.
| Control group (n = 63) | KD group (n = 73) | P | |
|---|---|---|---|
| Number of adverse events | 22 | 29 | |
| MedDRA system organ class: | 0.26 | ||
| Gastrointestinal disorders | 2/22 | 5/29 | |
| Diarrhea | 0 | 2 | |
| Nausea | 2 | 1 | |
| Vomiting | 0 | 2 | |
| Investigations | 6/22 | 8/29 | |
| Fibrinogen decreased | 6 | 6 | |
| Cholesterol high | 0 | 2 | |
| Metabolism and nutrition disorders | 7/22 | 13/29 | |
| Anorexia | 3 | 2 | |
| Hypertriglyceridemia | 0 | 10 | |
| Hypokalemia | 1 | 1 | |
| Hyponatremia | 3 | 0 | |
| Nervous system disorders | 5/22 | 1/29 | |
| Dizziness | 1 | 0 | |
| Headache | 1 | 0 | |
| Somnolence | 3 | 1 | |
| Psychiatric disorders | 2/22 | 1/29 | |
| Agitation | 1 | 0 | |
| Restlessness | 1 | 1 | |
| Renal and urinary disorders | 0/22 | 1/29 | |
| Renal calculi | 0 | 1 |