Table 5.

Numbers of Infants and Children Meeting Adverse Event Case Definitions in Domains of Interest for the Surveillance Monitoring for ART Toxicities Study and Estimated Prevalence of Adverse Events Between 2007 and 2010

Case Description	No. of Evaluated	Effective Sample Sizea	Meeting Trigger		AE Rate in those Meeting Trigger and With AE Evaluations		Estimated AE Prevalence	95% CI	Adjusted AE Prevalence Assuming an 80% Trigger Sensitivity	95% CI
			No. of Subjects	%	No. of Subjects/Total	%
Impaired growth	2,238	1,275	351	15.6	74/200	37.0	5.80	4.58, 7.23	7.29	5.93, 8.86
Metabolic abnormality	1,364	934	365	26.8	113/250	45.2	12.10	10.08, 14.36	15.12	12.86, 17.56
Neurologic diagnoses	2,171	2,082	122	5.6	77/117	65.8	3.70	2.93, 4.60	4.61	3.75, 5.60
Neurodevelopmental impairment	1,101	1,101	39	3.5	39/39	100	3.54	2.53, 4.81	4.43	3.31, 5.84
Laboratory toxicity (other than lactate)	2,149	1,322	13	0.6	5/8	62.5	0.38	0.12, 0.88	0.45	0.17, 0.99
Elevated lactate	1,980	1,681	106	5.4	39/90	43	2.32	1.65, 3.16	2.90	2.16, 3.84
Severe language impairment	1,050	1,050	114	10.9	114/114	100	10.86	9.04, 12.90	13.62	11.60, 15.84
Sensorineural or mixed hearing loss	940	745	29	3.1	2/23	8.70	0.27	0.03, 0.97	0.34	0.05, 1.02

Abbreviation: AE, adverse event; CI, confidence interval.

^aEffective sample size calculated based on percentage meeting trigger with complete follow-up to evaluate AE applied to the total number of participants evaluated for the trigger.