Table 3.
Clinical Adverse Events (AEs).
| Variable | Raltegravir and OBT (n = 462) |
Placebo and OBT (n = 237) |
|---|---|---|
| Duration on therapy, mean weeks | 93.0 | 59.3 |
| PYR at risk | 823.8 | 269.4 |
| AEs | ||
| Any | 92.9 (52.1) | 88.6 (78.0) |
| Drug-relateda | 58.4 (32.8) | 58.6 (51.6) |
| Serious | 25.3 (14.2) | 22.4 (19.7) |
| Serious drug-related | 2.8 (1.6) | 3.8 (3.3) |
| Deaths | 2.8 (1.6) | 3.0 (2.6) |
| Requiring discontinuation of treatment | 3.7 (2.1) | 5.1 (4.5) |
| Most common drug-relatedb | ||
| Abdominal distension | 2.2 (1.2) | 1.7 (1.5) |
| Diarrhea | 3.2 (1.8) | 5.1 (4.5) |
| Nausea | 4.1 (2.3) | 4.6 (4.1) |
| Vomiting | 1.5 (0.8) | 2.1 (1.9) |
| Fatigue | 3.2 (1.8) | 0.8 (0.7) |
| Pyrexia | 0.9 (0.5) | 2.5 (2.2) |
| Headache | 4.8 (2.7) | 5.1 (4.5) |
NOTE. Data are percentage of patients with AEs (rate of AEs, cases per 100 person-years [PYR]), unless otherwise indicated. OBT, optimized background therapy.
a
Determined by the investigator to be possibly, probably, or definitely related to raltegravir or placebo (alone or in combination with OBT).
b
Incidence ≥2%, any intensity.