TABLE 5.
Summary of Adverse Events (AEs)
| Double-Blind Phase |
Entire Study Period |
|||
|---|---|---|---|---|
| Raltegravir (N = 133) | Placebo (N = 45) | Raltegravir (N = 133) | Placebo* (N = 45) | |
| Duration of follow-up (wks), median (range) | 40 (3–59) | 24 (12–50) | 115 (3–138) | 25 (12–131) |
| Clinical adverse events, n (%) | 115 (86) | 37 (82) | 130 (98) | 38 (84) |
| Drug related† (DR) AE | 61 (46) | 24 (53) | 77 (58) | 26 (58) |
| Diarrhea | 2 (2) | 5 (11) | 2 (2) | 5 (11) |
| Nausea | 10 (8) | 5 (11) | 10 (8) | 5 (11) |
| Fatigue | 5 (4) | 1 (2) | 6 (5) | 1 (2) |
| Headache | 6 (5) | 2 (4) | 7 (5) | 2 (4) |
| Injection-site reaction | 0 | 1 (2) | 12 (9) | 3 (7) |
| Serious AE | 14 (11) | 3 (7) | 18 (14) | 3 (7) |
| Serious DR AE | 2 (2) | 2 (4) | 2 (2) | 2 (4) |
| Death | 2 (2) | 0 (0) | 4 (3) | 0 (0) |
| Discontinuations due to AE | 2 (2) | 1 (2) | 4 (3) | 1 (2) |
| Discontinuations due to DR AE | 0 (0) | 1 (2) | 0 (0) | 1 (2) |
| Laboratory adverse events, n (%) | 36 (27) | 11 (24) | 44 (33) | 12 (27) |
| Drug related† (DR) AE | 22 (17) | 8 (18) | 29 (22) | 8 (18) |
| Serious AE | 0 (0) | 0 (0) | 1 (1) | 0 (0) |
| Serious DR AE | 0 (0) | 0 (0) | 1 (1) | 0 (0) |
| Death | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Discontinuations due to AE | 1 (1) | 0 (0) | 1 (1) | 0 (0) |
| Discontinuations due to DR AE | 1 (1) | 0 (0) | 1 (1) | 0 (0) |
Raltegravir and placebo were administered with OBT.
N = number of patients randomized and treated at start of study.
*
Six patients from placebo treatment group entered open-label extension and received raltegravir.
†
Related to raltegravir or placebo (alone or with OBT); specific events listed occurred in ≥5% of any group.