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
Table 2: Summary of overall adverse events: up to week 96 and 144 FAS (randomized phase), and open-label extension (beyond week 144).