Table 2. Patients with adverse events during lopinavir/ritonavir monotherapy compared with triple therapy, and number of adverse events according to grade severity.
| Patients |
MT (n = 146) |
TT (n = 76) |
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| N | % | N | % | P (Fisher’s exact test) | ||
| Total of patients with adverse events | 26 | 17.8 | 11 | 14.3 | 0.573 | |
| Patients with serious adverse events | 6 | 4.1 | 1 | 1.3 | 0.426 | |
| Adverse events |
MT (n = 45) |
TT (n = 18) |
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| According to seriousness | Serious adverse events (Grade IV) | 8 | 17.8 | 1 | 5.6 | 0.426 |
| Non-serious adverse events (Grade I-III) | 37 | 82.2 | 17 | 94.4 | ||
| Number of non-serious adverse events according to intensity | Mild (Grade I) | 30 | 81.1 | 10 | 58.8 | 0.119 |
| Moderate (Grade II) | 6 | 16.2 | 7 | 41.2 | ||
| Severe (Grade III) | 1 | 2.7 | 0 | 0 | ||
| Number of non-serious adverse events according to causality | Not related | 31 | 83.8 | 14 | 82.4 | 0.275 |
| Possibly not related | 1 | 2.7 | 2 | 11.8 | ||
| Possibly related | 4 | 10.8 | 0 | 0 | ||
| Probably related | 1 | 2.7 | 1 | 5.9 | ||
| Number of non-serious adverse events according to action taken | None | 29 | 78.4 | 15 | 88.2 | 0.457 |
| Dose reduction | 0 | 0 | 0 | 0 | ||
| Temporary treatment interruption | 1 | 2.7 | 0 | 0 | ||
| Permanent treatment discontinuation | 4 | 10.8 | 0 | 0 | ||
| Others | 3 | 8.1 | 2 | 11.8 | ||
Per-protocol analysis.
MT, monotherapy; TT, triple therapy.