Table 2.
Safety-relevant laboratory events, events probably related to the intervention and safety-relevant events leading to hospitalization during the intervention period
| Description | KD, n (%) | WF, n (%) | Control, n (%) | |
|---|---|---|---|---|
| AST/ALT | >ULN to 3.0× ULN (>50–150 U/L) | 1 (4) | 0 | 1 (5) |
| >3.0× to 5.0× ULN (>150–250 U/L) | 0 | 0 | 0 | |
| Creatinine | up to 1.5× increase baseline | 0 | 0 | 0 |
| >1.5–3.0× increase baseline | 0 | 0 | 0 | |
| Uric acid | >ULN without gout specific symptoms (>7 mg/dL) | 4 (17) | 1 (5) | 1 (5) |
| >ULN with gout specific symptoms (>7 mg/dL) | 0 | 0 | 0 | |
| Triglycerides | 150–300 mg/dL | 1 (4) | 3 (16) | 1 (5) |
| >300–500 mg/dL | 2 (8) | 0 | 1 (5) | |
| Cholesterol | >ULN (200 mg/dL) to 300 mg/dL | 3 (13) | 0 | 0 |
| >300–400 mg/dL | 1 (4) | 0 | 0 | |
| Events probably related to the intervention | orthostatic symptoms | 4 (17) | 4 (21) | 0 |
| keto flu associated | 10 (43)∗ | 3 (16) | 0 | |
| reflux symptoms | 0 | 1 (5) | 0 | |
| Safety-relevant event with hospitalization | appendicitis | 1 (4) | 0 | 0 |
| cyst infection | 0 | 0 | 1 (5) | |
| nephrolithiasis | 1 (4) | 0 | 0 |
Safety-relevant laboratory events during the intervention period are reported per study arm along with the respective percentage within the study arm. All safety-relevant events were grouped into larger superordinate groups. Superordinate groups (see also Table S3) that contained at least one event which was considered probably associated with the intervention are shown together with the sum of all events contained in this group and the respective percentages per study arm. All safety-relevant events leading to hospitalization after initiation of the intervention period are shown as well as their frequencies and percentages per study arm. Safety-relevant events were defined as new events or a significant worsening of pre-existing conditions during the intervention, thresholds defined according CTCAE criteria. Potential differences between the intervention groups and the control group were investigated using chi squared tests.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; KD, ketogenic diet group; ULN, upper limit normal; WF, water fasting group.
aSignificantly different occurrence of the event in the corresponding intervention group compared with the control group (p < 0.05).