Table 4 Adverse events in the KD and control groups over 6 months.

Number of adverse events

22

29

MedDRA system organ class:

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