Table 3.

Incidence of Primary and Secondary Endpoint Events by Treatment Arm

					Co-trimoxazole vs Chloroquine		Co-trimoxazole vs No prophylaxis
Endpoint	Co-trimoxazole (n = 500, Pt-years = 1654), n (ratea)	Chloroquine (n = 500, Pt-years = 1646), n (ratea)	No Prophylaxis (n = 499, Pt-years = 1658), n (ratea)	Total (N = 1499, Pt-years = 4958), n (ratea)	Rate Ratio (95% CI)	P	Rate Ratio (95% CI)	P
Adjudicated WHO stage 3+ event or deathb	54 (3.3)	69 (4.2)	69 (4.2)	192 (3.9)	.78 (.55, 1.11)	.17	.79 (.55, 1.12)	.18
WHO stage 2 event, adjudicated WHO stage 3+ event, or deathc	66 (4.0)	94 (5.7)	97 (5.8)	257 (5.2)	.70 (.51, .96)	.026	.68 (.50, .93)	.017
Malariad, e	63 (3.8)	49 (3.0)	465 (28.0)	577 (11.6)	1.28 (.49, 3.33)	.61	.14 (.07, .27)	<.001
Bacterial infectiond, f	437 (26.4)	591 (35.9)	586 (35.3)	1614 (32.6)	.74 (.63, .87)	<.001	.75 (.64, .88)	<.001
Grade 3+ adverse eventd	209 (12.6)	244 (14.8)	239 (14.4)	692 (14.0)	.85 (.66, 1.10)	.21	.88 (.68, 1.12)	.31

Column header counts are the number of randomized participants. Abbreviations: CI, confidence interval; Pt-years, patient-years; WHO, World Health Organization.

^aIncidence rate per 100 participant-years of observation through the last visit in the database.

^bIncludes deaths not otherwise classified as a WHO Stage 3 + event.

^cInvestigator-reported WHO Stage 2 events are included because WHO Stage 2 events are not adjudicated. Deaths are included if not otherwise classified as a WHO Stage 2 event per investigator or adjudicated WHO Stage 3 + event.

^dRate ratio CIs and P values were adjusted for overdispersion using the Pearson’s chi-square scale. Rate ratios present the rate in co-trimoxazole participants relative to participants in the experimental group.

^eAdverse event report of malaria or if no adverse event report, laboratory-confirmed malaria.

^fLaboratory-confirmed bacterial infection or unconfirmed, suspected bacterial infection.