Table 4.
Summary of patients with adverse events through 48 weeks
| Low-dose TPV/r group n (%) |
High-dose TPV/r group n (%) |
Total N (%) |
||
|---|---|---|---|---|
| Total no. of patients treated | 58 (100) | 57 (100) | 115 (100) | |
| Most frequently occuring AEs in >10% of patients* | ||||
| Vomiting | 19 (32.8) | 24 (42.1) | 43 (37.4) | |
| Cough | 14 (24.1) | 17 (29.8) | 31 (27.0) | |
| Diarrhea | 13 (22.4) | 15 (26.3) | 28 (24.3) | |
| Pyrexia | 16 (27.6) | 12 (21.1) | 28 (24.3) | |
| Nausea | 9 (15.5) | 10 (17.5) | 19 (16.5) | |
| Nasopharyngitis | 8 (13.8) | 7 (12.3) | 15 (13.0) | |
| Headache | 8 (13.8) | 6 (10.5) | 14 (12.2) | |
| Total no. of patients with any AE | 54 (93.1) | 54 (94.7) | 108 (93.9) | |
| Total no. of patients with any study drug–related AE | 28 (48.3) | 34 (59.6) | 62 (53.9) | |
| Total no. of patients with a serious AE | 16 (27.6) | 13 (22.8) | 29 (25.2) | |
| Total no. of patients with AEs leading to discontinuation of study drug | 6 (10.3) | 4 (7.0) | 10 (8.7) | |
*
Values shown are for numbers of patients, not numbers of AEs
Low-dose TPV/r = tipranavir 290 mg/m2 plus ritonavir 115 mg/m2
High-dose TPV/r = tipranavir 375 mg/m2 plus ritonavir 150 mg/m2
AE = adverse event
GGT = gamma-glutamyl transferase