IR-XR post48an (%) IR-IR post48bn (%) XR-XR post48cn (%) TotalN (%)
Number of patients 130 (100) 13 (100) 276 (100) 419 (100)
Patients with any AE 112(86.2) 8 (61.5) 250 (90.6) 370 (88.3)
Patients with investigator-defined drug-related AEs 4 (3.1) 0 (0) 7 (2.5) 11 (2.6)
Patients with AEs leading to discontinuation of trial drugd 0 (0) 0 (0) 4 (1.4) 4 (1.0)
Patients with seriousAEse 17 (13.1) 3 (23.1) 54 (19.6) 74 (17.7)
Fatal 1 (0.8) 0 (0) 2 (0.7) 3 (0.7)
Immediately life-threatening 2 (1.5) 0 (0) 2 (0.7) 4 (1.0)
Disability/incapacitating 0 (0) 0 (0) 1 (0.4) 1 (0.2)
Required hospitalization 17 (13.1) 3 (23.1) 47 (17.0) 67 (16.0)
Prolonged hospitalization 0 (0) 0 (0) 1 (0.4) 1 (0.2)
Congenital anomaly 0 (0) 0 (0) 0 (0) 0 (0)
Other 0 (0) 0 (0) 7 (2.5) 7 (1.7)
Patients with DAIDS grade 3/4 AEs
DAIDS grade 3 or 4 AEs 10 (7.7) 1 (7.7) 31 (11.2) 42 (10)
DAIDS grade 4 AEs 2 (1.5) 0 (0) 8 (2.9) 10 (2.4)
Any study drug-related DAIDS grade 3 or 4 AEs 0 (0) 0 (0) 1 (0.4) 1 (0.2)
Any study drug-related DAIDS grade 4 AEs 0 (0) 0 (0) 0 (0) 0 (0)
Notes: Notes: AE=adverse event; FAS=full analysis set; IR=immediate release; NVP=nevirapine; SAE=serious adverse event; XR=extended release. Percentages are calculated using total number of patients per treatment as the denominator.
Medical Dictionary for Regulatory Activities (MeDRA) version 14.1 was used for reporting.
aPatients randomized to NVP IR and elected to change to NVP XR during the post-week 48 exposure.
bThe post-week 48 exposure of patients randomized to NVP IR, who chose to remain on NVP IR after week 48.
cThe post-week 48 exposure of patients randomized to NVP XR who elected to remain on NVP XR after week 48.
dPost-week 48, 4 patients (all in the NVP XR post48 group) experienced AEs leading to study drug discontinuation (n=2 infections and infestations; n=2 psychiatric disorders).
eA patient may be counted in >1 SAE category.
Table 4: Overall summary of adverse events post week 48 (FAS).