Table 3.
Clinical adverse events
| ON (N=100) | NI (N=100) | p value | |
|---|---|---|---|
| CNS (headache, insomnia, depression etc.) | 15 (24%) | 16 (23%) | >0·99 |
| Fatigue | 8 (13%) | 7 (10%) | >0·99 |
| Gastrointestinal (nausea, vomiting, diarrhea etc.) | 13 (21%) | 16 (23%) | 0·69 |
| High blood pressure | ‥ | 8 (11%) | 0·0021 |
| Increase of liver enzymes | 5 (8%) | 6 (9%) | >0·99 |
| Respiratory (cough, bronchitis, pneumonia etc.) | 10 (16%) | 8 (11%) | 0·81 |
| Surgical (wound infections) | 4 (6%) | 3 (4%) | >0·99 |
| Other | 8 (13%) | 7 (10%) | >0·99 |
| ≥1 adverse event | 32 (32%) | 29 (29%) | 0·76 |
| ≥1 serious adverse event* | 4 (4%) | 3 (3%) | >0·99 |
| Discontinued owing to adverse events | ‥ | 1 (1%) | >0·99 |
Data are number (%). CNS – central nervous system.
*
Four serious adverse events were registered for ON (two deaths due to overdose, one from AIDS and one death due to pancreatic cancer) and three serious adverse events were registered for NI (two deaths due to heart disease and one death from trauma).