| |
Up to week 96 FAS |
Up to week 144 FAS |
IR patients in open-label extension (post- week 144) |
| |
NVP IR 200 mg bid N = 506 n (%) |
NVP XR 400 mg qd N = 505 n (%) |
NVP IR 200 mg bid N = 506 n (%) |
NVP XR 400 mg qd N = 505 n (%) |
NVP XR 400 mg qd N = 315 n (%) |
| Any AE |
470 (92.9) |
459 (90.9) |
472 (93.3) |
471 (93.3) |
141 (44.8) |
| Investigator-defined drug-related AE |
134 (26.5) |
109 (21.6) |
135 (26.7) |
118 (23.4) |
5 (1.6) |
| AEs leading to discontinuation of trial drug |
52 (10.3) |
44 (8.7) |
54 (10.7) |
43 (8.5) |
0 (0.0) |
| Serious AEs* |
76 (15.0) |
78 (15.4) |
83 (16.4) |
93 (18.4) |
9 (2.9) |
| Fatal |
5 (1.0) |
3 (0.6) |
7 (1.4) |
3 (0.6) |
0 (0.0) |
| Immediately life-threatening |
3 (0.6) |
3 (0.6) |
5 (1.0) |
5 (1.0) |
0 (0.0) |
| Disability/incapacity |
0 (0.0) |
0 (0.0) |
1 (0.2) |
1 (0.2) |
1 (0.3) |
| Required hospitalisation |
65 (12.8) |
68 (13.5) |
71 (14.0) |
81 (16.0) |
8 (2.5) |
| Prolonged hospitalisation |
4 (0.8) |
3 (0.6) |
4 (0.8) |
4 (0.8) |
0 (0.0) |
| Congenital anomaly |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Other |
9 (1.8) |
10 (2.0) |
11 (2.2) |
12 (2.4) |
1 (0.3) |
| DAIDS grade 3 or 4 AEs |
112 (22.1) |
94 (8.6) |
124 (24.5) |
111 (22.0) |
8 (2.5) |
| DAIDS grade 4 AEs |
26 (5.1) |
21 (4.2) |
28 (5.5) |
25 (5.0) |
3 (1.0) |
| Study drug–related DAIDS grade 3 or 4 AEs |
38 (7.5) |
28 (5.5) |
39 (7.7) |
29 (5.7) |
0 (0.0) |
| Study drug–related DAIDS grade 4 AEs |
11 (2.2) |
7 (1.4) |
11 (2.2) |
7 (1.4) |
0 (0.0) |
*A patient may be counted in more than one seriousness criterion.Percentages are calculated using total number of patients per treatment as the denominator.AE, adverse event; bid, twice daily; DAIDS, Division of Acquired Immunodeficiency Syndrome; FAS, full analysis set; NVP IR, nevirapine immediate release; NVP XR, nevirapine extended release; qd, once daily