Table 4.
Adverse events: incidence and toxicity scores.*
| Study group | ||||
|---|---|---|---|---|
| Adverse event | Group 1: nelfinavir/ritonavir 2000/200 mg (n = 9) | Group 2: nelfinavir/ritonavir 2000/400 mg (n = 9) | Group 3: nelfinavir/ritonavir 2500/200 mg (n = 8)* | All groups: (n = 26) |
| Incidence (any severity)† | ||||
| Diarrhoea | 100 | 78 | 50 | 77 |
| Flatulence | 56 | 78 | 38 | 58 |
| Nausea | 11 | 56 | 25 | 31 |
| Vomiting | 0 | 11 | 25 | 12 |
| Abdominal pain | 22 | 44 | 50 | 38 |
| Asthenia | 11 | 22 | 38 | 23 |
| Fatigue/somnolence | 22 | 56 | 75 | 50 |
| Fever | 0 | 0 | 13 | 4 |
| Headache | 56 | 33 | 25 | 38 |
| Skin reaction or rash | 22 | 33 | 63 | 38 |
| Taste perversion | 11 | 11 | 25 | 15 |
| Peroral paraesthesia | 33 | 11 | 13 | 19 |
| Peripheral paraesthesia | 22 | 22 | 13 | 19 |
| Arthralgia | 22 | 22 | 25 | 23 |
| Myalgia | 11 | 22 | 13 | 15 |
| Median severity score‡ | 1.5 | 2.5 | 3.1 | 2.4 |
Data are from all participants, including those who withdrew. One participant in group 3 withdrew informed consent before taking the drugs and before the first evaluation of adverse events.
Incidence expressed as the percentage of participants who reported a particular adverse event at least once.
A severity score of 3.0 represents three mild adverse events, or one moderate adverse event (2 points) plus a mild one, or one severe adverse event (3 points).