Effects on mortality of a nutritional intervention for malnourished HIV-infected adults referred for antiretroviral therapy: a randomised controlled trial

Table 4 Effect of intervention on adverse events (AEs)

		Events	Event rate per 100 person-years (95% CI)	Rate ratio (95% CI) ^a	P value
Clinical AEs
Hospitalisation	LNS-VM	170	76.3 (65.6–88.6)	0.87 (0.71–1.07)	0.19
	LNS	190	87.8 (76.2–101.2)
All serious clinical adverse events^b	LNS-VM	250	112.2 (99.1–127.0)	0.89 (0.75–1.06)	0.20
All serious clinical adverse events^b	LNS	272	125.7 (111.6–141.6)
Severe laboratory AEs ^c
Potassium >6.5 mmol/L	LNS-VM	29	13.0 (9.0–18.7)	1.66 (0.91–3.02)	0.097
	LNS	17	7.9 (4.9–12.6)
Potassium <2.5 mmol/L	LNS-VM	28	12.6 (8.7–18.2)	0.82 (0.50–1.36)	0.44
	LNS	33	15.3 (10.8–21.5)
Phosphate <0.65 mmol/L	LNS-VM	86	38.7 (31.2–47.7)	0.73 (0.55–0.97)	0.03
	LNS	114	52.7 (43.9–63.3)
Abnormally high electrolyte levels ^d
Potassium >5.5 mmol/L	LNS-VM	117	52.5 (43.8–62.9)	1.60 (1.19–2.15)	0.002
	LNS	71	32.8 (26.0–41.4)
Phosphate >1.45 mmol/L	LNS-VM	650	219.6 (270.1–314.9)	1.23 (1.10–1.37)	<0.001
	LNS	513	237.1 (217.5–258.6)

CI, Confidence interval; LNS, Lipid-based nutritional supplement without added vitamins and minerals; LNS-VM, Lipid nutritional supplement with added vitamins and minerals.
^aAccounting for repeat events by patient; ^bDeath, hospitalisation, life-threatening events, permanently disabling, congenital abnormality, cancer, drug overdose; ^cPlasma potassium or phosphate levels meeting DAIDS criteria severity 3 or 4; ^dDAIDS criteria severity at least 1 for potassium and above normal [31] for phosphate for which DAIDS has no high level cut-offs.

ISSN: 1741-7015