Table 2.
Clinical adverse events in the ANRS 130 Apollo trial
| Adverse event | No. (%) of patients |
||
|---|---|---|---|
| Enfuvirtide group (n = 100) | Control group (n = 94) | Total (n = 194) | |
| Clinical adverse events | |||
| Any grade | 92 (92) | 85 (90) | 177 (91) |
| Any grade and trial treatment related | 61 (61) | 52 (55) | 113 (58) |
| Grades 3 and 4 | 23 (23) | 28 (30) | 51 (26) |
| Grades 3 and 4 and trial treatment related | 7 (7) | 8 (9) | 15 (8) |
| Serious | 28 (28) | 27 (29) | 55 (28) |
| Serious and study treatment related | 9 (9) | 13 (14) | 22 (11) |
| AIDS events | 20 (20) | 12 (13) | 32 (16) |
| IRIS | 15 (15) | 20 (21) | 35 (18) |
| Deaths | 2 (2) | 2 (2) | 4 (2) |