TABLE 3.

Safety in Women During Pregnancy and Up to 1 Month After Delivery^*

	Intensification Group, (N = 89)	Observational Group, (N = 234)	P †	All Women (N = 323)
At least one SAE, n (%)	4 (4%)	21 (9%)	0.245	25 (8%)
SAEs, n	4	23		27
HIV related, n	1	1		2
Pregnancy related, n	0	8		8
Delivery related, n	1	5		6
Possibly ART related, n	0	1		1
Infections, n	1	5		6
Others, n	1	3		4
Metabolic toxicity at least once at any visit	19 (21%)	68 (29%)	0.206	87 (27%)
Anemia grade ≥2, n	1	12	0.123	13
Fasting glucose grade ≥2, n	0	6	0.193	6
Fasting cholesterol grade ≥3, n	12	35	0.860	47
Fasting triglycerides grade ≥2, n	1	6	0.678	7
Total bilirubin grade ≥1, n	3	13	0.571	16
Alanine aminotransferase grade ≥2, n	1	4	>0.99	5
Rashes
At delivery, n	1	0	0.276	1
7–10 days postpartum, n	0	0	—	0
Delivery outcomes
Preterm (<37 weeks’ GA), n (%)	8 (9%)	24 (10%)	0.837	32 (10%)
Very preterm (<34 weeks’ GA), n (%)	0 (0%)	4 (2%)	0.579	4 (1%)
Stillborn, n (%)	0 (0%)	0 (0%)	—	0 (0%)
Low birth weight (<2500 g), n (%)	8 (9%)	58 (25%)	0.001	66 (20%)
Very low birth weight (<2000 g), n (%)	1 (1%)	9 (4%)	0.295	10 (3%)
Small for GA (<10th percentile), n (%)	1 (1%)	9 (4%)	0.295	10 (3%)

^*The total number shown for each group is the number of women who delivered in the study.

^†The Fisher exact test was used to compare proportions, and the Wilcoxon rank-sum test was used to compare distributions of continuous data.