Table 4.
Clinical adverse events
| Up to week 96 (double-blind phase) | Up to week 156 (double-blind phase) | Up to week 240 (entire study) | ||||
|---|---|---|---|---|---|---|
|
|
|
|
||||
| Raltegravir (n=462; 824 person-years) | Placebo (n=237; 269 person-years) | Raltegravir (n=462; 1061 person-years) | Placebo (n=237; 326 person-years) | Raltegravir and open- label raltegravir (n=462; 1433 person-years) | Placebo and open-label raltegravir (n=237; 397 person-years) | |
| Any adverse event | 429 (93%; 52·1) | 210 (89%; 78·0) | 435 (94%; 41·0) | 214 (90%; 65·6) | 438 (95%; 30·6) | 214 (90%; 53·9) |
|
| ||||||
| Drug-related adverse event* | 270 (58%; 32·8) | 139 (59%; 51·6) | 277 (60%; 26·1) | 145 (61%; 44·5) | 281 (61%; 19·6) | 146 (62%; 36·8) |
|
| ||||||
| Serious adverse event | 117 (25%; 14·2) | 53 (22%; 19·7) | 135 (29%; 12·7) | 54 (23%; 16·6) | 155 (34%; 10·8) | 61 (26%; 15·4) |
|
| ||||||
| Serious drug-related adverse event | 13 (3%; 1·6) | 9 (4%; 3·3) | 16 (4%; 1·5) | 10 (4%; 3·1) | 17 (4%; 1·2) | 10 (4%; 2·5) |
|
| ||||||
| Deaths | 13 (3%; 1·6) | 7 (3%; 2·6) | 17 (4%; 1·6) | 8 (3%; 2·5) | 23 (5%; 1·6) | 9 (4%; 2·3) |
|
| ||||||
| Discontinued because of adverse event | 17 (4%; 2·1) | 12 (5%; 4·5) | 23 (5%; 2·2) | 13 (5%; 4·0) | 29 (6%; 2·0) | 14 (6%; 3·5) |
|
| ||||||
| Most common† drug-related adverse events | ||||||
| Abdominal distension | 10 (2%; 1·2) | 4 (2%; 1·5) | 11 (2%; 1·0) | 4 (2%; 1·2) | 11 (2%; 0·8) | 4 (2%; 1·0) |
| Diarrhoea | 15 (3%; 1·8) | 12 (5%; 4·5) | 17 (4%; 1·6) | 12 (5%; 3·7) | 18 (4%; 1·3) | 12 (5%; 3·0) |
| Nausea | 19 (4%; 2·3) | 11 (5%; 4·1) | 19 (4%; 1·8) | 12 (5%; 3·7) | 19 (4%; 1·3) | 12 (5%; 3·0) |
| Vomiting | 7 (2%; 0·8) | 5 (2%; 1·9) | 6 (1%; 0·6) | 5 (2%; 1·5) | 6 (1%; 0·4) | 5 (2%; 1·3) |
| Fatigue | 15 (3%; 1·8) | 2 (1%; 0·7) | 15 (3%; 1·4) | 3 (1%; 0·9) | 16 (3%; 1·1) | 4 (2%; 1·0) |
| Pyrexia | 4 (1%; 0·5) | 6 (3%; 2·2) | 4 (1%; 0·4) | 6 (3%; 1·8) | 4 (1%; 0·3) | 6 (3%; 1·5) |
| Headache | 22 (5%; 2·7) | 12 (5%; 4·5) | 22 (5%; 2·1) | 12 (5%; 3·7) | 22 (5%; 1·5) | 12 (5%; 3·0) |
Data are n (%; events per 100 person-years at risk).
*
Decided by the investigator to be possibly, probably, or definitely related to raltegravir or placebo (alone or in combination with optimum background treatment).
†
Incidence ≥2% in any group, of any intensity.