Table 3:
Adverse events
| Control group (n=15) |
0·0625 mg/kg group (n=16) |
0·125 mg/kg group (n=16) |
0·25 mg/kg group (n=15) |
0·5 mg/kg group (n=17) |
|
|---|---|---|---|---|---|
| Participants with an adverse event | 6 (40%) | 9 (56%) | 10 (63%) | 6 (40%) | 11 (65%) |
| Number of adverse events | 20 | 13 | 16 | 10 | 20 |
| Number drug related* | 3 | 0 | 1 | 0 | 0 |
| Headache | |||||
| Mild | 2 | 4 | 1 | 2 | 3 |
| Moderate | 2 | 0 | 1 | 1 | 0 |
| Abdominal pain | |||||
| Mild | 2 | 2 | 2 | 1 | 1 |
| Fever | |||||
| Mild | 0 | 3 | 0 | 3 | 1 |
| Loss of appetite | |||||
| Mild | 3 | 0 | 2 | 0 | 1 |
| Fatigue | |||||
| Mild | 2 | 0 | 2 | 0 | 1 |
| Moderate | 0 | 0 | 1 | 0 | 0 |
| Fatigue | |||||
| Mild | 1 | 0 | 0 | 1 | 3 |
| Nausea | |||||
| Mild | 1 | 0 | 2 | 0 | 2 |
| Runny nose | |||||
| Mild | 1 | 0 | 2 | 1 | 0 |
| Dizziness | |||||
| Mild | 1 | 1 | 0 | 1 | 0 |
| Muscle aches | |||||
| Mild | 1 | 0 | 1 | 0 | 1 |
| Diarrhoea | |||||
| Mild | 0 | 1 | 0 | 0 | 1 |
| Respiratory infection | |||||
| Mild | 0 | 1 | 1 | 0 | 0 |
| Back pain | |||||
| Mild | 0 | 0 | 0 | 0 | 1 |
| Moderate | 2 | 0 | 0 | 0 | 0 |
| Burning with urination | |||||
| Mild | 0 | 0 | 0 | 0 | 1 |
| Pain with urination | |||||
| Mild | 0 | 0 | 0 | 0 | 1 |
| Dark urine | |||||
| Mild | 0 | 0 | 0 | 0 | 1 |
| Rhinobronchitis | |||||
| Mild | 0 | 0 | 1 | 0 | 0 |
| Shortness of breath | |||||
| Mild | 1 | 0 | 0 | 0 | 0 |
| Vomiting | |||||
| Mild | 0 | 1 | 0 | 0 | 0 |
| Whitlow | |||||
| Moderate | 0 | 0 | 0 | 1 | |
| Joint osteoarthritis in the legs | |||||
| Moderate | 1 | 0 | 0 | 0 | 0 |
There were no severe or serious adverse events. All events were self-reported. Mild events were defined as those causing no or mlnlmal Interference with usual social and functional activities; moderate events as those causing greater than minimaI interference; and severe events as those causing inability to perform usual social and functional activities. * Defined as probably or definitely related to study treatment.