Overall summary of adverse events post week 48.

	IR-XR post48^an (%)	IR-IR post48^bn (%)	XR-XR post48^cn (%)	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 drug^d	0 (0)	0 (0)	4 (1.4)	4 (1.0)
Patients with seriousAEs^e	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).

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