Table 5. Maternal SAEs during intervention period (enrollment to 9 mo post partum), number resulting in ARV substitution, and proportion of women initiated on ARV who required substitution.

Serious Adverse Event		Total n Women with SAE (n = 522)	Number of Women Requiring an ARV Substitution for Each SAE/Illnessa	Number of Maternal ARV Substituted (%)
				NVP (n = 310)	ZDV (n = 522)	NFV (n = 212)
Potentially ARV-related	Neutropenia	36	5	0	4 (0.8%)	1 (0.5%)
	Anemia	31	14	0	14 (2.7%)	0
	Anemia and neutropenia	9	3	0	3 (0.6%)	0
	Hepatotoxicityb	27	17	15 (4.8%)	2 (0.4%)	0
	Rash	10	8	8 (2.6%)	0	0
	Hepatotoxicity and rashc	6	6	6 (1.9%)	2 (0.4%)	0
Illness requiring ARV change	TB treatmentd	13	10	10 (3.2%)	1 (0.2%)	0
	DVT treatment	2	2	2 (0.6%)	0	0
	Hyperbilirubinemia	2	1	1 (0.3%)	0	0
Other SAEs	Malaria	23	0	—	—	—
	Pneumonia	7	0	—	—	—
	Death	6	0	—	—	—
	Gastroenteritis	3	0	—	—	—
	Other	19	0	0	0	0
Total		194	66	42 (13.5%)	26 (5%)	1 (0.5%)

^aEach participant only reported once for primary reason for ARV substitution between enrollment and 9-mo post partum.

^bIncludes one participant where SAE attributed to ZDV, but stopped all ARVs.

^cIncludes two participants who stopped both NVP and ZDV.

^dIncludes one participant who stopped both NVP and ZDV.

DVT, deep venous thrombosis.