Table 5.
Frequency of treatment-related adverse events and their severity.a
| Repeated doseb | 420 mg/kg bw/day
|
1071 mg/kg bw/day
|
2142 mg/kg bw/day
|
|||
|---|---|---|---|---|---|---|
| Adverse event | Male (n = 6) | Female (n = 6) | Male (n = 6) | Female (n = 6) | Male (n = 6) | Female (n = 6) |
| Flatulence | 1 (mild) | – | – | – | 3 (mild) | 2 (mild) |
| Nausea | – | 1 (mild) | – | – | 4 (mild) | 3 (mild) |
| 1 (mod.) | ||||||
| Diarrhea | – | – | 1 (mild) | – | 3 (mild) | 1 (mild) |
| 1 (mod.) | 3 (mod.) | |||||
| Constipation | – | – | – | – | 2 (mild) | 1 (mild) |
| Vomiting | – | – | – | – | 1(mild) | 1 (mild) |
| 2 (mod.) | 2 (mod.) | |||||
| 1 (severe) | ||||||
| Decreased appetite | – | – | 1 (mild) | – | – | – |
| Abdominal distension | – | – | – | – | 6 (mild) | 3 (mild) |
| Abdominal pain | – | – | – | – | 1 (mild) | 1 (mod.) |
| Abdominal pain – lower | – | – | – | – | – | 1 (mild) |
| Abdominal pain – upper | – | – | – | – | 1 (mild) | 2 (mild) |
| 1 (mod.) | ||||||
| Occult blood positive | 1 (mild) | – | – | – | – | – |
| Rhinitis | – | – | – | – | 2 (mild) | – |
| Palpitations | – | – | – | – | 1 (mild) | 1 (mild) |
| Chest pain | – | – | – | – | – | 1 (mod.) |
| Dyspnoea | – | – | – | – | – | 1 (mod.) |
| Dizziness | – | 1 (mild) | – | – | 4 (mild) | 1 (mild) |
| Headache | – | – | – | – | 6 (mild) | 2 (mild) |
| Euphoria | – | 1 (mild) | – | – | – | – |
| Fatigue | – | – | – | – | 2 (mild) | 2 (mild) |
| Lethargy | – | – | – | – | 1 (mild) | – |
| Somnolence | – | – | – | – | – | 1 (mild) |
| Insomnia | – | – | – | – | 1 (mild) | – |
| Anxiety | – | – | – | – | 1 (mild) | – |
| Number of participants reporting at least one AE | 2 | 2 | 1 | 0 | 6 | 6 |
| Total number of AEs reportedc | 3 | 4 | 2 | 0 | 50 | 42 |
AE = adverse event; bw = body weight; mod. = moderate.
a
The number of individuals reporting the symptoms listed is provided.
B
Ketone monoesters were administered as three divided doses of 140 mg/kg bw, 357 mg/kg bw, and 714 mg/kg bw over the course of the day.
c
Includes repeat occurrences of the same adverse event in the same individual.