[ { "trial": "T01", "entries": [ { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 13.5, "lower": 6.7, "upper": 19.8, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": 97047, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": 93191, "rate_per_1000_person_years": 16.5, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": true, "where": "pmid:29694816 (main), Results, 'Primary results' (community-level intention-to-treat analysis over all 4 inter-census periods; placebo rate in the same paragraph); children from Table 1 (baseline)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi", "estimate": { "measure": "percent reduction", "value": 5.7, "lower": -9.7, "upper": 18.9, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": 39386, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": 39534, "rate_per_1000_person_years": 9.6, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29694816 (main), Results, 'Subgroup results' (Figure 2); placebo rate from 'Primary results'; children from Table 1 (baseline)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger", "estimate": { "measure": "percent reduction", "value": 18.1, "lower": 10.0, "upper": 25.5, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": 40345, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": 35747, "rate_per_1000_person_years": 27.5, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29694816 (main), Results, 'Subgroup results' (Figure 2); placebo rate from 'Primary results'; children from Table 1 (baseline)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Tanzania", "estimate": { "measure": "percent reduction", "value": 3.4, "lower": -21.2, "upper": 23.0, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": 17316, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": 17910, "rate_per_1000_person_years": 5.5, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29694816 (main), Results, 'Subgroup results' (Figure 2); placebo rate from 'Primary results'; children from Table 1 (baseline)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-5 months", "period": "whole", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 24.9, "lower": 10.6, "upper": 37.0, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29694816 (main), Results, 'Subgroup results' (Figure 3)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "first inter-census period", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 7.3, "lower": -5.9, "upper": 18.8, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29694816 (main), Results, 'Subgroup results' (Figure 4)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "last inter-census period", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 22.0, "lower": 10.6, "upper": 31.9, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29694816 (main), Results, 'Subgroup results' (Figure 4)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "year 1", "subgroup": "Niger", "estimate": { "measure": "percent reduction", "value": 16.0, "lower": 5.7, "upper": 25.1, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 21.9, "rate_lower": 20.2, "rate_upper": 24.2 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 26.3, "rate_lower": 24.2, "rate_upper": 28.8 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:31167050 (extension), Table 2, MORDOR I distribution year 1" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "year 2", "subgroup": "Niger", "estimate": { "measure": "percent reduction", "value": 20.3, "lower": 10.6, "upper": 28.9, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 22.4, "rate_lower": 20.6, "rate_upper": 24.3 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 28.0, "rate_lower": 25.8, "rate_upper": 30.5 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:31167050 (extension), Table 2, MORDOR I distribution year 2" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "extension", "subgroup": "Niger", "estimate": { "measure": "percent reduction", "value": 3.5, "lower": -8.3, "upper": 14, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": 37497, "rate_per_1000_person_years": 23.3, "rate_lower": 21.4, "rate_upper": 25.5 }, "control": { "deaths": null, "person_years": null, "children": 33294, "rate_per_1000_person_years": 24.0, "rate_lower": 22.1, "rate_upper": 26.3 }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:31167050 (extension), Table 2, MORDOR II distribution year 3 (both arms given azithromycin), and Results 'Primary outcome'; children from Table 1 (start of MORDOR II)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger", "estimate": { "measure": "hazard ratio", "value": 0.81, "lower": 0.75, "upper": 0.87, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:30561577 (secondary), Results, relative hazard by country (Cox proportional hazard model)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi", "estimate": { "measure": "hazard ratio", "value": 0.96, "lower": 0.84, "upper": 1.14, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:30561577 (secondary), Results, relative hazard by country (Cox proportional hazard model)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Tanzania", "estimate": { "measure": "hazard ratio", "value": 0.996, "lower": 0.8, "upper": 1.24, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:30561577 (secondary), Results, relative hazard by country (Cox proportional hazard model)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger", "estimate": null, "treated": { "deaths": 1727, "person_years": null, "children": 40345, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 1888, "person_years": null, "children": 35747, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:31981558 (secondary), Results text (child deaths documented over 2 years of biannual censuses; children enrolled at baseline)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger", "estimate": { "measure": "incidence rate ratio", "value": 0.82, "lower": 0.75, "upper": 0.9, "level": 0.95 }, "treated": { "deaths": 1566, "person_years": null, "children": 40345, "rate_per_1000_person_years": 22.32, "rate_lower": 20.86, "rate_upper": 23.87 }, "control": { "deaths": 1735, "person_years": null, "children": 35747, "rate_per_1000_person_years": 27.26, "rate_lower": 25.5, "rate_upper": 29.13 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:31981558 (secondary), Table 3, 'Total' row (only deaths whose cause the verbal autopsy ascertained; negative binomial regression of community-level death counts); children from Results text (baseline)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi", "estimate": { "measure": "rate ratio", "value": 0.91, "lower": 0.79, "upper": 1.05, "level": 0.95 }, "treated": { "deaths": null, "person_years": 66837, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": 66935, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342837 (secondary), Results text; person-years from the denominators in Table 4" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi", "estimate": null, "treated": { "deaths": 564, "person_years": "66.84 thousand", "children": 43105, "rate_per_1000_person_years": 8.44, "rate_lower": 7.77, "rate_upper": 9.16 }, "control": { "deaths": 620, "person_years": "66.93 thousand", "children": 42825, "rate_per_1000_person_years": 9.26, "rate_lower": 8.56, "rate_upper": 10.02 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342840 (secondary), Table 4, 'Total' column (person-years printed in thousands); children enrolled from Table 2" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi, Monkey Bay zone", "estimate": null, "treated": { "deaths": 73, "person_years": "10.96 thousand", "children": null, "rate_per_1000_person_years": 6.66, "rate_lower": 5.3, "rate_upper": 8.38 }, "control": { "deaths": 53, "person_years": "7.58 thousand", "children": null, "rate_per_1000_person_years": 6.99, "rate_lower": 5.34, "rate_upper": 9.15 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342840 (secondary), Table 4, Monkey Bay column (person-years printed in thousands)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi, Chilipa zone", "estimate": null, "treated": { "deaths": 119, "person_years": "11.60 thousand", "children": null, "rate_per_1000_person_years": 10.26, "rate_lower": 8.57, "rate_upper": 12.28 }, "control": { "deaths": 134, "person_years": "12.28 thousand", "children": null, "rate_per_1000_person_years": 10.91, "rate_lower": 9.21, "rate_upper": 12.93 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342840 (secondary), Table 4, Chilipa column (person-years printed in thousands)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi, Makanjira zone", "estimate": null, "treated": { "deaths": 87, "person_years": "9.33 thousand", "children": null, "rate_per_1000_person_years": 9.32, "rate_lower": 7.56, "rate_upper": 11.5 }, "control": { "deaths": 89, "person_years": "10.08 thousand", "children": null, "rate_per_1000_person_years": 8.83, "rate_lower": 7.18, "rate_upper": 10.87 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342840 (secondary), Table 4, Makanjira column (person-years printed in thousands)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi, Namwera zone", "estimate": null, "treated": { "deaths": 135, "person_years": "17.59 thousand", "children": null, "rate_per_1000_person_years": 7.67, "rate_lower": 6.48, "rate_upper": 9.08 }, "control": { "deaths": 191, "person_years": "18.05 thousand", "children": null, "rate_per_1000_person_years": 10.58, "rate_lower": 9.18, "rate_upper": 12.19 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342840 (secondary), Table 4, Namwera column (person-years printed in thousands)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi, Mangochi zone", "estimate": null, "treated": { "deaths": 150, "person_years": "17.36 thousand", "children": null, "rate_per_1000_person_years": 8.64, "rate_lower": 7.36, "rate_upper": 10.14 }, "control": { "deaths": 153, "person_years": "18.94 thousand", "children": null, "rate_per_1000_person_years": 8.08, "rate_lower": 6.89, "rate_upper": 9.46 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342840 (secondary), Table 4, Mangochi column (person-years printed in thousands)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Tanzania", "estimate": null, "treated": { "deaths": 190, "person_years": 32514, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 200, "person_years": 33638, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:34559801 (secondary), Results text (rates printed per 100 person-years: 0.58 azithromycin, 0.59 placebo)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-5 months", "period": "whole", "subgroup": "Tanzania", "estimate": { "measure": "incidence rate ratio", "value": 0.8, "lower": 0.46, "upper": 1.39, "level": 0.95 }, "treated": { "deaths": 25, "person_years": 2190.1, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 32, "person_years": 2230.5, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:34559801 (secondary), Table 1 (age-group specific negative binomial regression at the community level; rates printed per 100 person-years)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "6-11 months", "period": "whole", "subgroup": "Tanzania", "estimate": { "measure": "incidence rate ratio", "value": 0.92, "lower": 0.57, "upper": 1.48, "level": 0.95 }, "treated": { "deaths": 42, "person_years": 3599.2, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 45, "person_years": 3597.1, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:34559801 (secondary), Table 1 (age-group specific negative binomial regression at the community level; rates printed per 100 person-years)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "12-23 months", "period": "whole", "subgroup": "Tanzania", "estimate": { "measure": "incidence rate ratio", "value": 1.03, "lower": 0.72, "upper": 1.48, "level": 0.95 }, "treated": { "deaths": 59, "person_years": 7564.1, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 60, "person_years": 7926.0, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:34559801 (secondary), Table 1 (age-group specific negative binomial regression at the community level; rates printed per 100 person-years)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "24-59 months", "period": "whole", "subgroup": "Tanzania", "estimate": { "measure": "incidence rate ratio", "value": 1.05, "lower": 0.74, "upper": 1.5, "level": 0.95 }, "treated": { "deaths": 64, "person_years": 19165.5, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 63, "person_years": 19888.5, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:34559801 (secondary), Table 1 (age-group specific negative binomial regression at the community level; rates printed per 100 person-years)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, valid weight recorded at entry", "estimate": { "measure": "rate ratio", "value": 0.72, "lower": 0.62, "upper": 0.83, "level": 0.95 }, "treated": { "deaths": 523, "person_years": 16153, "children": 14243, "rate_per_1000_person_years": 32.4, "rate_lower": 29.3, "rate_upper": 35.5 }, "control": { "deaths": 661, "person_years": 14699, "children": 12979, "rate_per_1000_person_years": 45.0, "rate_lower": 40.3, "rate_upper": 49.7 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:32931496 (secondary), Table 2, 'Overall' row (bootstrap at the community level)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ ≥ −2", "estimate": { "measure": "rate ratio", "value": 0.73, "lower": 0.61, "upper": 0.87, "level": 0.95 }, "treated": { "deaths": 387, "person_years": 12610, "children": 10988, "rate_per_1000_person_years": 30.7, "rate_lower": 27.0, "rate_upper": 34.4 }, "control": { "deaths": 480, "person_years": 11435, "children": 9966, "rate_per_1000_person_years": 42.0, "rate_lower": 36.9, "rate_upper": 47.3 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:32931496 (secondary), Table 2, WAZ category moderate to severe, ≥ −2 (bootstrap at the community level)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ < −2", "estimate": { "measure": "rate ratio", "value": 0.69, "lower": 0.54, "upper": 0.86, "level": 0.95 }, "treated": { "deaths": 136, "person_years": 3543, "children": 3255, "rate_per_1000_person_years": 38.4, "rate_lower": 32.4, "rate_upper": 44.9 }, "control": { "deaths": 181, "person_years": 3264, "children": 3013, "rate_per_1000_person_years": 55.4, "rate_lower": 46.7, "rate_upper": 64.9 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:32931496 (secondary), Table 2, WAZ category moderate to severe, < −2 (bootstrap at the community level)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ ≥ −3", "estimate": { "measure": "rate ratio", "value": 0.74, "lower": 0.63, "upper": 0.84, "level": 0.95 }, "treated": { "deaths": 460, "person_years": 14599, "children": 12796, "rate_per_1000_person_years": 31.5, "rate_lower": 28.3, "rate_upper": 35.0 }, "control": { "deaths": 568, "person_years": 13293, "children": 11671, "rate_per_1000_person_years": 42.7, "rate_lower": 37.6, "rate_upper": 47.6 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:32931496 (secondary), Table 2, WAZ category severe, ≥ −3 (bootstrap at the community level)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ < −3", "estimate": { "measure": "rate ratio", "value": 0.61, "lower": 0.44, "upper": 0.84, "level": 0.95 }, "treated": { "deaths": 63, "person_years": 1554, "children": 1447, "rate_per_1000_person_years": 40.5, "rate_lower": 30.9, "rate_upper": 49.7 }, "control": { "deaths": 93, "person_years": 1406, "children": 1308, "rate_per_1000_person_years": 66.1, "rate_lower": 53.7, "rate_upper": 79.4 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:32931496 (secondary), Table 2, WAZ category severe, < −3 (bootstrap at the community level)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ ≥ −2", "estimate": { "measure": "hazard ratio", "value": 0.73, "lower": 0.62, "upper": 0.85, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32931496 (secondary), Table 3 (Cox sensitivity analysis), 'Azithromycin within strata of WAZ'; text: 27% lower, 95% CI 15–38" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ < −2", "estimate": { "measure": "hazard ratio", "value": 0.7, "lower": 0.55, "upper": 0.89, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32931496 (secondary), Table 3 (Cox sensitivity analysis), 'Azithromycin within strata of WAZ'; text: 30% lower, 95% CI 11–45" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ ≥ −3", "estimate": { "measure": "hazard ratio", "value": 0.74, "lower": 0.64, "upper": 0.85, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32931496 (secondary), Table 3 (Cox sensitivity analysis), 'Azithromycin within strata of WAZ'" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ < −3", "estimate": { "measure": "hazard ratio", "value": 0.62, "lower": 0.45, "upper": 0.86, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32931496 (secondary), Table 3 (Cox sensitivity analysis), 'Azithromycin within strata of WAZ'; text: 38% lower, 95% CI 14–55" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger", "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 40345, "rate_per_1000_person_years": 22.5, "rate_lower": 21.4, "rate_upper": 23.5 }, "control": { "deaths": null, "person_years": null, "children": 35747, "rate_per_1000_person_years": 27.5, "rate_lower": 26.2, "rate_upper": 28.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38100110 (secondary), Results text ('As previously reported'); children from Table 1 (baseline)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger, 0 km from nearest primary health center", "estimate": { "measure": "incidence rate ratio", "value": 1.0, "lower": 0.83, "upper": 1.19, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38100110 (secondary), Table 2, 'Azithromycin vs placebo within strata of distance' (adjusted IRR, negative binomial regression adjusted for community mean age)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger, 1 km from nearest primary health center", "estimate": { "measure": "incidence rate ratio", "value": 0.96, "lower": 0.83, "upper": 1.12, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38100110 (secondary), Table 2, 'Azithromycin vs placebo within strata of distance' (adjusted IRR, negative binomial regression adjusted for community mean age)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger, 5 km from nearest primary health center", "estimate": { "measure": "incidence rate ratio", "value": 0.84, "lower": 0.77, "upper": 0.93, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38100110 (secondary), Table 2, 'Azithromycin vs placebo within strata of distance' (adjusted IRR, negative binomial regression adjusted for community mean age)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger, 10 km from nearest primary health center", "estimate": { "measure": "incidence rate ratio", "value": 0.72, "lower": 0.62, "upper": 0.83, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38100110 (secondary), Table 2, 'Azithromycin vs placebo within strata of distance' (adjusted IRR, negative binomial regression adjusted for community mean age)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger", "estimate": { "measure": "incidence rate ratio", "value": 0.82, "lower": 0.74, "upper": 0.9, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:34508582 (secondary, abstract only), BACKGROUND (intention-to-treat result restated)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger, treated children (complier average causal effect)", "estimate": { "measure": "incidence rate ratio", "value": 0.8, "lower": 0.72, "upper": 0.88, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 16.6, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 20.9, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:34508582 (secondary, abstract only), RESULTS" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger, untreated children (spillover)", "estimate": { "measure": "incidence rate ratio", "value": 0.91, "lower": 0.69, "upper": 1.21, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 33.6, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 34.4, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:34508582 (secondary, abstract only), RESULTS" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-60 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 97047, "rate_per_1000_person_years": 14.6, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": 93191, "rate_per_1000_person_years": 16.5, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "NCT02047981 posted results, primary outcome 'All-cause Mortality Rate in Children Aged 1-60 Months', time frame 24 months" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-60 months", "period": "extension", "subgroup": "Niger", "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 37497, "rate_per_1000_person_years": 23.3, "rate_lower": 21.4, "rate_upper": 25.5 }, "control": { "deaths": null, "person_years": null, "children": 33294, "rate_per_1000_person_years": 24.0, "rate_lower": 22.1, "rate_upper": 26.3 }, "adjusted_for_clustering": null, "primary": true, "where": "NCT02047981 posted results, primary outcome 'All-cause Mortality Rate in Children Aged 1-60 Months', Niger-only contingency study with all communities given azithromycin in year 3, time frame 36 months" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-60 months", "period": "whole", "subgroup": "Niger", "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 40345, "rate_per_1000_person_years": 22.3, "rate_lower": 20.9, "rate_upper": 23.9 }, "control": { "deaths": null, "person_years": null, "children": 35747, "rate_per_1000_person_years": 27.3, "rate_lower": 25.5, "rate_upper": 29.1 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT02047981 posted results, secondary outcome 'Cause-specific Mortality Rate ... Verbal Autopsy (Niger Only)', 'Total' row (verbal-autopsy causes), time frame 24 months" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-60 months", "period": "not printed (adverse events module)", "subgroup": null, "estimate": null, "treated": { "deaths": 3262, "person_years": null, "children": 97047, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 3392, "person_years": null, "children": 93191, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "NCT02047981 posted results, adverse events module, all-cause deaths by group (ages from the group descriptions, children aged 1 month to 60 months)" } ], "deaths_ascertainment": "Biannual census of every community: 5 census visits (census periods starting December 2014, August 2015, February 2016, August 2016 and February 2017), 323,302 person-years monitored; no randomization units lost to follow-up after the initial census; an independent team re-censused a subset of households and found 95% (257/271) in Malawi, 92% (286/310) in Niger and 95% (4544/4791) in Tanzania enumerated on the first census; the share of children recorded as moved or unknown did not differ between arms (P=0.71 and P=0.36) (pmid:29694816). Niger extension: censuses February 2017 to August 2017, September 2017 to January 2018, February 2018 to August 2018, no communities lost to follow-up; status moved or unknown in 4079 of 64,225 (6.4%) and 4685 of 72,108 (6.5%) cases (pmid:31167050). Niger: 1727 azithromycin and 1888 placebo child deaths documented over 2 years of biannual censuses; verbal autopsy completed for 1590 (92·1%) and 1749 (92·6%); it confirmed the census death for 3301 (98·9%) of 3339 cases, and 22 (1·3%) azithromycin and 11 (0·6%) placebo census deaths were found alive (pmid:31981558). Malawi: 1,184 deaths, verbal autopsy completed for 1,131 (pmid:32342837). Niger malnutrition analysis: over the 2-year study period 5,189 children were lost to follow-up, a similar percentage in each arm (pmid:32931496). In 16 Niger communities, 10.9% of children had unknown vital status at some time during the 5-year census period (pmid:37903434). Registry: deaths were assessed via biannual population census; in Tanzania, a census at 6-monthly intervals with verbal autopsy for child deaths (NCT02047981).", "coverage": "Main report: overall 90.3% (±10.6%) azithromycin and 90.4% (standard deviation 10.1%) placebo; Malawi 91.5% (±6.1%) azithromycin and 91.5% (±6.4%) placebo; Niger 94.5% (±6.0%) azithromycin and 94.5% (±6.7%) placebo; Tanzania 85.5% (±13.6%) azithromycin and 86.1% (±12.3%) placebo (pmid:29694816). The Niger verbal-autopsy paper gives Niger a mean coverage of 90·3% (SD 10·6) azithromycin and 90·4% (10·1) placebo across the four distributions (pmid:31981558), the main report's figures for all countries. Niger malnutrition paper: greater than 91% over the 4 inter-census periods in both arms among children 1–59 months (pmid:32931496). Niger compliance abstract: mean 90% (SD 10%) in both arms (pmid:34508582). Tanzania paper: 89.9±14.1% azithromycin vs 90.5±12.7% placebo (pmid:34559801). Niger extension year, both arms given azithromycin: 92.0% (±6.6%) in the original azithromycin communities and 91.3% (±7.2%) in the original placebo communities (pmid:31167050). Niger infants 1–5 months in the safety substudy: caregivers reported 70.2% (N = 1,201) received study treatment, no difference between arms (P = 0.22) (pmid:30419040).", "notes": "(1) Reports give different numbers for Malawi: the main report's Table 1 has 152 communities per arm, 39,386 azithromycin and 39,534 placebo children, and 111,559 person-years for both arms; the Malawi verbal-autopsy and cost papers have 334 randomization units (167 per arm), 43,105 azithromycin and 42,825 placebo children enrolled, and 133,772 person-years (66,837 azithromycin and 66,935 placebo; the cost paper prints 66.84 and 66.93 thousand). Malawi whole-follow-up estimates: 5.7% lower (-9.7 to 18.9) in the main report, hazard ratio 0.96 (0.84-1.14) in the timing paper, rate ratio 0.91 (0.79-1.05) in the verbal-autopsy paper. (2) Niger whole-follow-up estimates: 18.1% lower (10.0 to 25.5) in the main report, hazard ratio 0.81 (0.75-0.87) in the timing paper, IRR 0.82 (0.74-0.90) restated in the compliance abstract, IRR 0.82 (0.75-0.90) for deaths with a verbal-autopsy cause. Tanzania: 3.4% lower (-21.2 to 23.0) in the main report, hazard ratio 0.996 (0.80-1.24) in the timing paper, and 190 vs 200 deaths with no ratio in the Tanzania paper. (3) The main report prints person-years only for both arms together (323,302; Malawi 111,559, Niger 145,597, Tanzania 66,146) and no azithromycin-arm rate; the registry's 24-month primary outcome gives 14.6 azithromycin and 16.5 placebo per 1000 person-years. Children in main-report entries are baseline-census counts from Table 1. Only the overall 13.5% is described as a community-level analysis; the main report doesn't say how the country, 1-5 month and period intervals were estimated, and the country and period intervals aren't labelled 95% (coded 0.95). (4) Two entries count only deaths whose cause the verbal autopsy ascertained (1566 of 1727 azithromycin and 1735 of 1888 placebo census deaths): pmid:31981558 Table 3 'Total' and the registry's Niger cause-specific 'Total', which prints the same row as 22.3 [20.9, 23.9] and 27.3 [25.5, 29.1] where the paper prints 22·32 (20·86–23·87) and 27·26 (25·50–29·13). (5) The extension report (pmid:31167050) covers 594 communities (303 azithromycin, 291 placebo), Niger's in the main report's Table 1, and the registry calls the extension 'Niger only'. In its third year both arms received azithromycin (the original placebo communities their first year, the original azithromycin communities their third), so the 'extension' entries compare a third year with a first year of azithromycin. Table 2's column is 'Difference between arms (randomized comparison)'; the text words the year-3 value as 'a relative 3.5% (95% CI -8.3% to 14%) more deaths in those communities randomized to the first year of treatment'; coded as percent reduction like years 1 and 2. The report calls the year-3 comparison its primary outcome and the registry lists it as a PRIMARY outcome, so both extension entries have primary true, though neither is the trial's 24-month primary analysis. (6) Not entries: the extension's within-arm before-after changes, which the report prints inconsistently (Table 2: 13.3% (5.8%—20.2%) P=0.007 and -3.6% (-12.3%—4.5%) P=0.50; text: -13.3% (95% CI, 5.8% to -20.2%) p=0.007 and -3.6% (-12.3% to 4.5%) p=0.50; Figure 2 caption: -13.0% (-21.5% to -3.7%) p=0.008 and 2.1% (-7.6 to 12.6%) p=0.69); the malnutrition paper's hazard ratios comparing underweight azithromycin children with higher-weight placebo children (0.93, 0.97) and its interaction contrasts; the distance paper's numbers needed to treat; and all rate differences (malnutrition overall −12.6 (−18.5 to −6.9), Malawi zones 0.33, 0.65, −0.50, 2.91, −0.57, total 0.82 per 1000 person-years). (7) The Tanzania paper's Table 1 also prints a 'Reduction in mortality' for each age band, the same rows as the IRRs extracted: 20% (-39% to 54%), 8% (-48% to 43%), -3% (-48% to 38%), -5% (-50% to 26%). Its rates are per 100 person-years and are left out of the per-1000 field (azithromycin/placebo: overall 0.58/0.59; 1-5 months 1.14/1.43; 6-11 months 1.17/1.25; 12-23 months 0.78/0.76; 24-59 months 0.33/0.32). (8) The malnutrition paper (pmid:32931496) analyses children who were 1-11 months old with a valid weight at their first census and follows them over the 2-year trial; 12,086 children 1-11 months were excluded for missing or implausible weight. Its Table 3 Cox hazard ratios are a sensitivity analysis; the text gives three of them as percentages: 27% lower in WAZ ≥ −2 (95% CI 15–38), 30% lower in WAZ < −2 (11–45), 38% lower in WAZ < −3 (14–55). (9) The distance paper's ratios are model estimates at fixed distances; the text gives them as mortality reductions of 0% (−19% to 17%), 4% (−12% to 17%), 16% (7%-23%) and 28% (17%-38%). Its arm rates are restated 'as previously reported' with 3615 deaths and 145 693 person-years for both arms. (10) The Malawi cost paper prints person-years in thousands (copied as text with 'thousand'); its zones are geographic subgroups within Malawi. (11) The timing paper and the Malawi cost paper's Table 4 don't print the age band; coded as the trial's 1-59 months. (12) The compliance abstract's treated-children (complier average causal effect) and untreated-children (spillover) analyses give deaths only for both arms together (2581 treated, 245 untreated). (13) The registry's adverse-events module prints no time frame; its denominators equal the 24-month primary outcome's. (14) The Malawi verbal-autopsy paper doesn't say how its all-cause rate ratio was modelled; its cause-specific tables use a random-effects Poisson model adjusting for clustering at the randomization unit." }, { "trial": "T02", "entries": [ { "comparison": "Azithro vs Placebo", "ages": "1-60 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 33173, "rate_per_1000_person_years": 24.8, "rate_lower": 23.1, "rate_upper": 26.5 }, "control": { "deaths": null, "person_years": null, "children": 33055, "rate_per_1000_person_years": 26.7, "rate_lower": 24.5, "rate_upper": 28.5 }, "adjusted_for_clustering": null, "primary": true, "where": "NCT03338244 posted results, primary outcome 'All-cause Mortality Rate in Children Aged 1-60 Months', time frame 24 months" }, { "comparison": "Azithro vs Placebo", "ages": "1-60 months", "period": "not printed (adverse events module)", "subgroup": null, "estimate": null, "treated": { "deaths": 1493, "person_years": null, "children": 33173, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 1584, "person_years": null, "children": 33055, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "NCT03338244 posted results, adverse events module, all-cause deaths by group (ages from the group descriptions, children aged 1 month to 60 months)" } ], "deaths_ascertainment": "Registry results only: deaths counted 'by presence on census and absence on sequential census due to death'. No number lost to follow-up is printed.", "coverage": "Not printed.", "notes": "(1) Only ClinicalTrials.gov results (NCT03338244) are available, and they print no ratio. (2) The primary outcome's population is described as 'Number of participants at the start of MORDOR III'; ages as in the outcome's title, 1-60 months. (3) The adverse-events module prints no time frame; its denominators (33173, 33055) equal the primary outcome's." }, { "trial": "T03", "entries": [ { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 14, "lower": 7, "upper": 22, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.9, "rate_lower": 11.3, "rate_upper": 12.6 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 13.9, "rate_lower": 13.0, "rate_upper": 14.8 }, "adjusted_for_clustering": true, "primary": true, "where": "pmid:39167806 (main, abstract only), RESULTS (one of three primary community-level mortality outcomes)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 6, "lower": -8, "upper": 19, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 22.3, "rate_lower": 20.0, "rate_upper": 24.7 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 23.9, "rate_lower": 21.6, "rate_upper": 26.2 }, "adjusted_for_clustering": true, "primary": true, "where": "pmid:39167806 (main, abstract only), RESULTS (one of three primary community-level mortality outcomes)" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 23, "lower": 11, "upper": 33, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 18.5, "rate_lower": 16.7, "rate_upper": 20.4 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 23.9, "rate_lower": 21.6, "rate_upper": 26.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40638118 (secondary), Results text (reduction worded as 'communities receiving any azithromycin compared with placebo'; arm rates in the preceding sentence)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 22.3, "rate_lower": 20.0, "rate_upper": 24.7 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 23.9, "rate_lower": 21.6, "rate_upper": 26.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40638118 (secondary), Results text (incidence rates among infants aged 1 to 11 months by arm)" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 18.5, "rate_lower": 16.7, "rate_upper": 20.4 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 22.3, "rate_lower": 20.0, "rate_upper": 24.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40638118 (secondary), Results text (incidence rates among infants aged 1 to 11 months by arm)" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "older sibling (12-59 months) in household", "estimate": { "measure": "incidence rate ratio", "value": 0.78, "lower": 0.65, "upper": 0.93, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:40638118 (secondary), Results text and Figure 2 (Poisson regression accounting for the adaptation and clustering)" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "no older sibling in household", "estimate": { "measure": "incidence rate ratio", "value": 0.91, "lower": 0.73, "upper": 1.15, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:40638118 (secondary), Results text and Figure 2 (Poisson regression accounting for the adaptation and clustering)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "older sibling (12-59 months) in household", "estimate": { "measure": "incidence rate ratio", "value": 0.96, "lower": 0.81, "upper": 1.14, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:40638118 (secondary), Results text and Figure 3 (Poisson regression accounting for the adaptation and clustering)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "no older sibling in household", "estimate": { "measure": "incidence rate ratio", "value": 0.9, "lower": 0.71, "upper": 1.12, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:40638118 (secondary), Results text and Figure 3 (Poisson regression accounting for the adaptation and clustering)" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "weighed during at least one round", "estimate": null, "treated": { "deaths": 334, "person_years": 18413, "children": null, "rate_per_1000_person_years": 18.1, "rate_lower": 15.9, "rate_upper": 20.1 }, "control": { "deaths": 374, "person_years": 15603, "children": null, "rate_per_1000_person_years": 24.0, "rate_lower": 21.4, "rate_upper": 26.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Table 2, 'Overall' row" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ ≥ −2", "estimate": null, "treated": { "deaths": 211, "person_years": 13909, "children": null, "rate_per_1000_person_years": 15.2, "rate_lower": 13.1, "rate_upper": 17.2 }, "control": { "deaths": 242, "person_years": 11821, "children": null, "rate_per_1000_person_years": 20.5, "rate_lower": 18.4, "rate_upper": 23.5 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Table 2, WAZ category moderate to severe, ≥−2" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ < −2", "estimate": { "measure": "percent reduction", "value": 23, "lower": 1, "upper": 41, "level": 0.95 }, "treated": { "deaths": 123, "person_years": 4504, "children": null, "rate_per_1000_person_years": 27.3, "rate_lower": 21.8, "rate_upper": 32.2 }, "control": { "deaths": 132, "person_years": 3781, "children": null, "rate_per_1000_person_years": 34.9, "rate_lower": 29.3, "rate_upper": 40.9 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Results text ('moderate to severe subgroup', figure 2) and Table 2, <−2" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ ≥ −3", "estimate": null, "treated": { "deaths": 268, "person_years": 16610, "children": null, "rate_per_1000_person_years": 16.1, "rate_lower": 13.9, "rate_upper": 18.1 }, "control": { "deaths": 305, "person_years": 14150, "children": null, "rate_per_1000_person_years": 21.6, "rate_lower": 19.5, "rate_upper": 24.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Table 2, WAZ category severe, ≥−3" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ < −3", "estimate": { "measure": "percent reduction", "value": 24, "lower": -5, "upper": 47, "level": 0.95 }, "treated": { "deaths": 66, "person_years": 1803, "children": null, "rate_per_1000_person_years": 36.6, "rate_lower": 26.9, "rate_upper": 44.7 }, "control": { "deaths": 69, "person_years": 1453, "children": null, "rate_per_1000_person_years": 47.5, "rate_lower": 37.1, "rate_upper": 58.4 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Results text ('severe underweight subgroup', figure 2) and Table 2, <−3" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "weighed during at least one round", "estimate": null, "treated": { "deaths": 313, "person_years": 13935, "children": null, "rate_per_1000_person_years": 22.5, "rate_lower": 20.0, "rate_upper": 25.2 }, "control": { "deaths": 374, "person_years": 15603, "children": null, "rate_per_1000_person_years": 24.0, "rate_lower": 21.4, "rate_upper": 26.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Table 2, 'Overall' row" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ ≥ −2", "estimate": null, "treated": { "deaths": 212, "person_years": 10660, "children": null, "rate_per_1000_person_years": 19.9, "rate_lower": 17.3, "rate_upper": 23.0 }, "control": { "deaths": 242, "person_years": 11821, "children": null, "rate_per_1000_person_years": 20.5, "rate_lower": 18.4, "rate_upper": 23.5 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Table 2, WAZ category moderate to severe, ≥−2" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ < −2", "estimate": { "measure": "percent reduction", "value": 11, "lower": -11, "upper": 32, "level": 0.95 }, "treated": { "deaths": 101, "person_years": 3275, "children": null, "rate_per_1000_person_years": 30.8, "rate_lower": 25.2, "rate_upper": 36.5 }, "control": { "deaths": 132, "person_years": 3781, "children": null, "rate_per_1000_person_years": 34.9, "rate_lower": 29.3, "rate_upper": 40.9 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Results text ('moderate to severe subgroup', figure 2) and Table 2, <−2" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ ≥ −3", "estimate": null, "treated": { "deaths": 269, "person_years": 12726, "children": null, "rate_per_1000_person_years": 21.2, "rate_lower": 18.8, "rate_upper": 23.9 }, "control": { "deaths": 305, "person_years": 14150, "children": null, "rate_per_1000_person_years": 21.6, "rate_lower": 19.5, "rate_upper": 24.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Table 2, WAZ category severe, ≥−3" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ < −3", "estimate": { "measure": "percent reduction", "value": 23, "lower": -11, "upper": 47, "level": 0.95 }, "treated": { "deaths": 44, "person_years": 1209, "children": null, "rate_per_1000_person_years": 36.4, "rate_lower": 26.8, "rate_upper": 46.4 }, "control": { "deaths": 69, "person_years": 1453, "children": null, "rate_per_1000_person_years": 47.5, "rate_lower": 37.1, "rate_upper": 58.4 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Results text ('severe underweight subgroup', figure 2) and Table 2, <−3" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "weighed during at least one round", "estimate": null, "treated": { "deaths": 334, "person_years": 18413, "children": null, "rate_per_1000_person_years": 18.1, "rate_lower": 15.9, "rate_upper": 20.1 }, "control": { "deaths": 313, "person_years": 13935, "children": null, "rate_per_1000_person_years": 22.5, "rate_lower": 20.0, "rate_upper": 25.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Table 2, 'Overall' row" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ ≥ −2", "estimate": null, "treated": { "deaths": 211, "person_years": 13909, "children": null, "rate_per_1000_person_years": 15.2, "rate_lower": 13.1, "rate_upper": 17.2 }, "control": { "deaths": 212, "person_years": 10660, "children": null, "rate_per_1000_person_years": 19.9, "rate_lower": 17.3, "rate_upper": 23.0 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Table 2, WAZ category moderate to severe, ≥−2" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ < −2", "estimate": null, "treated": { "deaths": 123, "person_years": 4504, "children": null, "rate_per_1000_person_years": 27.3, "rate_lower": 21.8, "rate_upper": 32.2 }, "control": { "deaths": 101, "person_years": 3275, "children": null, "rate_per_1000_person_years": 30.8, "rate_lower": 25.2, "rate_upper": 36.5 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Table 2, WAZ category moderate to severe, <−2" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ ≥ −3", "estimate": null, "treated": { "deaths": 268, "person_years": 16610, "children": null, "rate_per_1000_person_years": 16.1, "rate_lower": 13.9, "rate_upper": 18.1 }, "control": { "deaths": 269, "person_years": 12726, "children": null, "rate_per_1000_person_years": 21.2, "rate_lower": 18.8, "rate_upper": 23.9 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Table 2, WAZ category severe, ≥−3" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ < −3", "estimate": null, "treated": { "deaths": 66, "person_years": 1803, "children": null, "rate_per_1000_person_years": 36.6, "rate_lower": 26.9, "rate_upper": 44.7 }, "control": { "deaths": 44, "person_years": 1209, "children": null, "rate_per_1000_person_years": 36.4, "rate_lower": 26.8, "rate_upper": 46.4 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 (secondary), Table 2, WAZ category severe, <−3" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 153626, "rate_per_1000_person_years": 11.9, "rate_lower": 11.3, "rate_upper": 12.6 }, "control": { "deaths": null, "person_years": null, "children": 124617, "rate_per_1000_person_years": 13.9, "rate_lower": 13.0, "rate_upper": 14.8 }, "adjusted_for_clustering": null, "primary": true, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (1-59 Months Old)' (comparing the azithro 1-59 and placebo arms), time frame from 6 months up to 2.5 years" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 104374, "rate_per_1000_person_years": 13.8, "rate_lower": 12.9, "rate_upper": 14.8 }, "control": { "deaths": null, "person_years": null, "children": 124617, "rate_per_1000_person_years": 13.9, "rate_lower": 13.0, "rate_upper": 14.8 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (1-59 Months Old)', arm rows OG000 and OG002" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 153626, "rate_per_1000_person_years": 11.9, "rate_lower": 11.3, "rate_upper": 12.6 }, "control": { "deaths": null, "person_years": null, "children": 104374, "rate_per_1000_person_years": 13.8, "rate_lower": 12.9, "rate_upper": 14.8 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (1-59 Months Old)', arm rows OG001 and OG000" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 38573, "rate_per_1000_person_years": 22.3, "rate_lower": 10.0, "rate_upper": 24.7 }, "control": { "deaths": null, "person_years": null, "children": 32218, "rate_per_1000_person_years": 23.9, "rate_lower": 21.6, "rate_upper": 26.2 }, "adjusted_for_clustering": null, "primary": true, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (1-11 Months Old)' (comparing the azithro 1-11 and placebo arms), time frame from 6 months up to 2.5 years" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 38506, "rate_per_1000_person_years": 18.5, "rate_lower": 16.7, "rate_upper": 20.4 }, "control": { "deaths": null, "person_years": null, "children": 32218, "rate_per_1000_person_years": 23.9, "rate_lower": 21.6, "rate_upper": 26.2 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (1-11 Months Old)', arm rows OG001 and OG002" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 38506, "rate_per_1000_person_years": 18.5, "rate_lower": 16.7, "rate_upper": 20.4 }, "control": { "deaths": null, "person_years": null, "children": 38573, "rate_per_1000_person_years": 22.3, "rate_lower": 10.0, "rate_upper": 24.7 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (1-11 Months Old)', arm rows OG001 and OG000" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "12-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 115120, "rate_per_1000_person_years": 10.7, "rate_lower": 10.0, "rate_upper": 11.4 }, "control": { "deaths": null, "person_years": null, "children": 65801, "rate_per_1000_person_years": 12.2, "rate_lower": 11.3, "rate_upper": 13.1 }, "adjusted_for_clustering": null, "primary": true, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (12-59 Months Old)' (rates compared between azithro 1-11 and azithro 1-59 communities), time frame from 6 months up to 2.5 years" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "12-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 115120, "rate_per_1000_person_years": 10.7, "rate_lower": 10.0, "rate_upper": 11.4 }, "control": { "deaths": null, "person_years": null, "children": 92399, "rate_per_1000_person_years": 12.0, "rate_lower": 11.2, "rate_upper": 13.0 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (12-59 Months Old)', arm rows OG001 and OG002" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "12-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 65801, "rate_per_1000_person_years": 12.2, "rate_lower": 11.3, "rate_upper": 13.1 }, "control": { "deaths": null, "person_years": null, "children": 92399, "rate_per_1000_person_years": 12.0, "rate_lower": 11.2, "rate_upper": 13.0 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (12-59 Months Old)', arm rows OG000 and OG002" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "weighed during at least one round", "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 37943, "rate_per_1000_person_years": 18.1, "rate_lower": 15.9, "rate_upper": 20.1 }, "control": { "deaths": null, "person_years": null, "children": 31781, "rate_per_1000_person_years": 24, "rate_lower": 21.4, "rate_upper": 26.6 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, secondary outcome 'Mortality Rate by Weight-for-age Z-score Subgroup Among Infants Aged 1-11 Months' (overall rate for the analysis population, not stratified), arm rows OG001 and OG002" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "weighed during at least one round", "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 27842, "rate_per_1000_person_years": 22.5, "rate_lower": 20, "rate_upper": 25.2 }, "control": { "deaths": null, "person_years": null, "children": 31781, "rate_per_1000_person_years": 24, "rate_lower": 21.4, "rate_upper": 26.6 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, secondary outcome 'Mortality Rate by Weight-for-age Z-score Subgroup Among Infants Aged 1-11 Months' (overall rate for the analysis population, not stratified), arm rows OG000 and OG002" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "weighed during at least one round", "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 37943, "rate_per_1000_person_years": 18.1, "rate_lower": 15.9, "rate_upper": 20.1 }, "control": { "deaths": null, "person_years": null, "children": 27842, "rate_per_1000_person_years": 22.5, "rate_lower": 20, "rate_upper": 25.2 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, secondary outcome 'Mortality Rate by Weight-for-age Z-score Subgroup Among Infants Aged 1-11 Months' (overall rate for the analysis population, not stratified), arm rows OG001 and OG000" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-59 months", "period": "not printed (adverse events module)", "subgroup": null, "estimate": null, "treated": { "deaths": 1914, "person_years": null, "children": 153626, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 1923, "person_years": null, "children": 124617, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, adverse events module, all-cause deaths by group (ages from the group descriptions, children 1-59 months)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-59 months", "period": "not printed (adverse events module)", "subgroup": null, "estimate": null, "treated": { "deaths": 1666, "person_years": null, "children": 104374, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 1923, "person_years": null, "children": 124617, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, adverse events module, all-cause deaths by group (ages from the group descriptions, children 1-59 months)" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-59 months", "period": "not printed (adverse events module)", "subgroup": null, "estimate": null, "treated": { "deaths": 1914, "person_years": null, "children": 153626, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 1666, "person_years": null, "children": 104374, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, adverse events module, all-cause deaths by group (ages from the group descriptions, children 1-59 months)" } ], "deaths_ascertainment": "Census workers who were not aware of the group assignments monitored mortality twice yearly over the course of 2 years; communities analysed: 1229 of 1273 child azithromycin, 751 of 773 infant azithromycin, 929 of 954 placebo (pmid:39167806). Dynamic cohort: communities and children could enter, leave and re-enter the trial across intercensus intervals; 117 communities were excluded after randomization (39 with census inaccuracies, 7 refusals, 40 in insecure areas, 2 moved communities, 2 protocol deviations, 1 with only 1 census household, 26 with no person-time for infants); no communities were lost to follow-up (pmid:40638118). The underweight paper says 91 communities were excluded after randomisation because of national census inaccuracies (pmid:40147984). No number of children lost to follow-up is printed.", "coverage": "Not printed per arm. Mean (SD) treatment coverage across MDAs was 97.1% (5.5%) (pmid:40638118, eTable 1).", "notes": "(1) The main report is available only as an abstract. It assessed 'three primary community-level mortality outcomes (deaths per 1000 person-years), each examining a different age group and pairwise group comparison' and prints two of them (1-59 months, child azithromycin vs placebo; 1-11 months, infant azithromycin vs placebo); adjusted_for_clustering is true for those two because the outcomes are community-level. The registry gives the third primary outcome: 12-59 months, compared between the azithro 1-11 and azithro 1-59 arms, with no ratio. Totals for all arms together: 382,586 children, 419,440 person-years and 5503 deaths. (2) The registry prints each primary outcome's rates for all three arms, so each outcome gives an entry for every comparison; only the comparison the outcome names is marked primary. Its time frame for these outcomes is 'from 6 months up to 2.5 years', coded whole. (3) The registry prints the infant azithromycin arm's 1-11 month rate as 22.3 [10.0, 24.7]; the main abstract and the spillover paper print 22.3 (20.0 to 24.7). (4) The spillover paper's 23% (95% CI, 11%-33%) is 'the overall reduction in mortality at 1 to 11 months of age in communities receiving any azithromycin compared with placebo', of which 23.5% (1.2%-72.7%) is 'explained by treating infants with azithromycin' and 76.5% (27.3%-98.8%) 'by also treating children 12 to 59 months of age'. It is coded to Azithro 1-59 vs Placebo because only the child arm also treats children 12-59 months, but 'any azithromycin' could be read as both azithromycin arms together. The sibling-subgroup IRDs and interaction contrasts aren't extracted. Totals for infants 1-11 months, all arms: 1432 deaths and 69 590 person-years. (5) The underweight paper's population is children 1-11 months weighed in at least one round with a valid WAZ (97 572 children); its footnote says 'Results will differ slightly from the main trial results since this subgroup analysis uses a different subpopulation'. The registry's WAZ secondary outcome gives the same population's overall rates per arm (subgroup coded the same way). The paper's IRRs for its overall, WAZ ≥ −2 and WAZ ≥ −3 rows are only in a figure and supplementary table, so those entries carry the arm data without a ratio; IRDs (including the Dosso-region IRDs 18.6 and 12.2) are not ratios. Its percent reductions don't say whether their intervals account for clustering. (6) The adverse-events module prints no time frame; its denominators equal those of the 1-59 month primary outcome." }, { "trial": "T07", "entries": [ { "comparison": "Azithromycin-biannually vs Control", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 1.0, "lower": 0.83, "upper": 1.19, "level": 0.95 }, "treated": { "deaths": 437, "person_years": 37072.0, "children": 18040, "rate_per_1000_person_years": 11.8, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 335, "person_years": 28117.9, "children": 13187, "rate_per_1000_person_years": 11.9, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:41092331 (main), Results 'Primary Outcomes' and Table 2 (IRR adjusted for village size category); children: Table 1, infants at the first MDA" }, { "comparison": "Azithromycin-quarterly vs Control", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.93, "lower": 0.75, "upper": 1.15, "level": 0.95 }, "treated": { "deaths": 196, "person_years": 17409.5, "children": 8201, "rate_per_1000_person_years": 11.3, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 335, "person_years": 28117.9, "children": 13187, "rate_per_1000_person_years": 11.9, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:41092331 (main), Results 'Primary Outcomes' and Table 2 (IRR adjusted for village size category); children: Table 1, infants at the first MDA" }, { "comparison": "Azithromycin-quarterly vs Azithromycin-biannually", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.93, "lower": 0.76, "upper": 1.15, "level": 0.95 }, "treated": { "deaths": 196, "person_years": 17409.5, "children": 8201, "rate_per_1000_person_years": 11.3, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 437, "person_years": 37072.0, "children": 18040, "rate_per_1000_person_years": 11.8, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:41092331 (main), Results 'Primary Outcomes' and Table 2, 'Quarterly vs Biannual' column (IRR adjusted for village size category); children: Table 1, infants at the first MDA" }, { "comparison": "Azithromycin-biannually vs Control", "ages": "12-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 1.03, "lower": 0.85, "upper": 1.24, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41092331 (main), Results 'Secondary Outcomes' (untreated children aged 12-59 months at the time of MDA; Table S5)" }, { "comparison": "Azithromycin-quarterly vs Control", "ages": "12-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.97, "lower": 0.77, "upper": 1.22, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41092331 (main), Results 'Secondary Outcomes' (untreated children aged 12-59 months at the time of MDA; Table S5)" } ], "deaths_ascertainment": "968 deaths were recorded during the study among infants aged 1–11 months at the time of MDA; 149,201 infants received at least one dose, with 82,600 person-years at risk of follow-up time; 285,227 households registered, 27 declined; vital status unknown for 4,080 (2.7%) treated infants due to migration or other loss to follow-up: 2.8% in the control group, 2.7% in the biannual azithromycin group and 2.6% in the quarterly azithromycin group. The last MDA round in 128 villages was not completed because the study drug expired, and follow-up was truncated in 10 more villages. 967 deaths among untreated children aged 12–59 months at the time of MDA (pmid:41092331).", "coverage": "Not printed per arm. Of 9,085 planned MDA visits, 86.2% were completed on time, 1.0% early, 9.9% late and 2.9% missed, with similar completion between arms; the study drug could not be administered as planned in 10,094 (3.7%) of treatment visits, similar across groups; 149,201 infants received at least one dose, with 274,896 recorded treatments (pmid:41092331).", "notes": "(1) IRRs are 'Adjusted for stratified randomization factor (village size category)'; the Results don't say whether the intervals account for clustering. (2) Table 2 also prints incidence rate differences (−0.05, −0.91, −0.85 per 1000 person-years), not extracted. (3) The 12-59 month estimates are for children who were untreated and 12-59 months old at the time of MDA, from Table S5, which isn't among the sources. (4) Children in the 1-11 month entries are infants at the first MDA (Table 1), not the 149,201 infants treated over the trial. (5) Subgroup results by age, sex, WAZ and other factors are shown only in figures, with no numbers in the text." }, { "trial": "T08", "entries": [ { "comparison": "Biannual mass oral azithromycin + child health days vs Biannual mass placebo + child health days", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 1.04, "lower": 0.75, "upper": 1.46, "level": 0.95 }, "treated": { "deaths": 397, "person_years": 154051, "children": 201709, "rate_per_1000_person_years": 2.6, "rate_lower": 2.1, "rate_upper": 3.1 }, "control": { "deaths": 191, "person_years": 77364, "children": 100959, "rate_per_1000_person_years": 2.5, "rate_lower": 1.8, "rate_upper": 3.2 }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:41506755 (main), Results text and Table 2, birth history data (primary outcome)" }, { "comparison": "Biannual mass oral azithromycin + child health days vs Biannual mass placebo + child health days", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.98, "lower": 0.76, "upper": 1.26, "level": 0.95 }, "treated": { "deaths": 691, "person_years": 122519, "children": 167018, "rate_per_1000_person_years": 5.6, "rate_lower": 4.9, "rate_upper": 6.4 }, "control": { "deaths": 345, "person_years": 59710, "children": 80878, "rate_per_1000_person_years": 5.8, "rate_lower": 4.7, "rate_upper": 7.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41506755 (main), Results text and Table 2, census data (secondary outcome)" }, { "comparison": "Biannual mass oral azithromycin + child health days vs Biannual mass placebo + child health days", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 1.05, "lower": 0.77, "upper": 1.45, "level": 0.95 }, "treated": { "deaths": 496, "person_years": null, "children": 193248, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 247, "person_years": null, "children": 97205, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41506755 (main), Results text, secondary synthetic-cohort analysis of cumulative probabilities of mortality (children = live births; mortality per 1000 live births, not per person-year)" } ], "deaths_ascertainment": "Primary outcome from birth histories collected during the last census of the study: 55 clusters could not be reached because of insecurity (38 azithromycin, 17 placebo). Secondary outcome from the census data: 12 clusters lost to follow-up and not analysed because of insecurity (6 azithromycin, 6 placebo). Verbal autopsies were conducted for 1265 (78%) of the 1624 deaths (pmid:41506755).", "coverage": "Not printed per arm. Treatment coverage was 58.4% in the first round and exceeded 90% in all other rounds (online supplemental table 2) (pmid:41506755).", "notes": "(1) Three estimates of the same comparison come from different data: birth histories (the primary outcome, IRR 1.04), the census (secondary, IRR 0.98), and a synthetic cohort of live births (secondary, IRR 1.05). The synthetic-cohort mortality is per 1000 live births, 3.3 (95% CI 2.7 to 3.9) azithromycin and 3.1 (2.3 to 3.9) placebo, so the per-1000-person-years field is empty and 'children' holds live births. (2) The synthetic-cohort analysis doesn't print its age band; coded as the trial's 1-11 months. (3) A bias analysis for outcome misclassification gives IRD 0.13 (95% uncertainty interval −0.34 to 0.62), not a ratio. (4) Subgroup results (age group, sex, region, CSPS type) are only in online supplemental table 3, with no numbers in the text. (5) The Results don't say how the IRR intervals were estimated. (6) Table 1's baseline-census children (64 647 azithromycin, 30 699 placebo) differ from Table 2's N (birth history 201 709 and 100 959; census 167 018 and 80 878); entries use Table 2's." }, { "trial": "T04", "entries": [ { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.82, "lower": 0.67, "upper": 1.02, "level": 0.95 }, "treated": { "deaths": 498, "person_years": 60592, "children": 34399, "rate_per_1000_person_years": 8.2, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 588, "person_years": 58547, "children": 33847, "rate_per_1000_person_years": 10.0, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:38349371 Results text and Figure 3 (IRR, deaths, person-years, rates); NCT03676764 posted results: primary outcome 'All-cause Mortality Rate in Children Aged 1-59 Months' (34399 and 33847 children; 8.2 and 10.0 deaths per 1000 person-years) and adverse events module (deaths 498 of 34399 and 588 of 33847); pmid:41252743 Results (498 and 588 deaths, 'The primary outcome, all-cause mortality')" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.99, "lower": 0.72, "upper": 1.36, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38349371 Results text (prespecified subgroup analysis by age group) and Figure 3" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "12-23 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.92, "lower": 0.67, "upper": 1.27, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38349371 Results text (prespecified subgroup analysis by age group) and Figure 3" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "24-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.73, "lower": 0.57, "upper": 0.94, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38349371 Results text (prespecified subgroup analysis by age group) and Figure 3" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "year 1", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.76, "lower": 0.55, "upper": 1.04, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38349371 Results text ('first year of the study'; prespecified subgroup analysis by study year) and Figure 3" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "year 2", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.83, "lower": 0.62, "upper": 1.12, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38349371 Results text ('second year'; prespecified subgroup analysis by study year) and Figure 3" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "year 3", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.87, "lower": 0.65, "upper": 1.18, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38349371 Results text ('third year'; prespecified subgroup analysis by study year) and Figure 3" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.82, "lower": 0.66, "upper": 1.01, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.2, "rate_lower": 7.1, "rate_upper": 9.4 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 10.0, "rate_lower": 8.4, "rate_upper": 11.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41021553 Table 2 'Overall (Jan-Dec)'; pmid:40343013 Table 2 (same numbers)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "non-SMC season (Jan-Jun)", "estimate": { "measure": "incidence rate ratio", "value": 0.89, "lower": 0.68, "upper": 1.15, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 7.5, "rate_lower": 6.1, "rate_upper": 8.8 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.4, "rate_lower": 6.8, "rate_upper": 10.1 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41021553 Table 2 and Results; pmid:40343013 Table 2 and Results (same numbers); ppr:PPR1012955 abstract (0.89, 95% CI 0.68 to 1.15)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "during/post-SMC season (Jul-Dec)", "estimate": { "measure": "incidence rate ratio", "value": 0.77, "lower": 0.6, "upper": 0.98, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9, "rate_lower": 7.5, "rate_upper": 10.4 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.7, "rate_lower": 9.5, "rate_upper": 13.9 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41021553 Table 2 and Results; pmid:40343013 Table 2 and Results (same numbers); ppr:PPR1012955 abstract (0.77, 95% CI 0.60 to 0.98)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "during/post-SMC months (Jul-Dec), all SMC coverage levels ('Overall' row)", "estimate": { "measure": "incidence rate ratio", "value": 0.77, "lower": 0.6, "upper": 0.98, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.0, "rate_lower": 7.5, "rate_upper": 10.4 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.6, "rate_lower": 9.6, "rate_upper": 13.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 (SMC coverage level; Figure 5 note: analysis restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "during/post-SMC months (Jul-Dec), SMC coverage 30%", "estimate": { "measure": "incidence rate ratio", "value": 0.57, "lower": 0.2, "upper": 0.95, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.5, "rate_lower": 4.8, "rate_upper": 12.3 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 14.9, "rate_lower": 7.6, "rate_upper": 22.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 (SMC coverage level; Figure 5 note: analysis restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "during/post-SMC months (Jul-Dec), SMC coverage 40%", "estimate": { "measure": "incidence rate ratio", "value": 0.62, "lower": 0.3, "upper": 0.94, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.6, "rate_lower": 5.7, "rate_upper": 11.6 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 13.9, "rate_lower": 8.6, "rate_upper": 19.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 (SMC coverage level; Figure 5 note: analysis restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "during/post-SMC months (Jul-Dec), SMC coverage 50%", "estimate": { "measure": "incidence rate ratio", "value": 0.68, "lower": 0.42, "upper": 0.93, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.8, "rate_lower": 6.6, "rate_upper": 11 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 12.9, "rate_lower": 9.3, "rate_upper": 16.5 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 (SMC coverage level; Figure 5 note: analysis restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "during/post-SMC months (Jul-Dec), SMC coverage 60%", "estimate": { "measure": "incidence rate ratio", "value": 0.74, "lower": 0.54, "upper": 0.93, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.9, "rate_lower": 7.3, "rate_upper": 10.5 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 12, "rate_lower": 9.7, "rate_upper": 14.4 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 (SMC coverage level; Figure 5 note: analysis restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "during/post-SMC months (Jul-Dec), SMC coverage 70%", "estimate": { "measure": "incidence rate ratio", "value": 0.8, "lower": 0.62, "upper": 0.99, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9, "rate_lower": 7.5, "rate_upper": 10.5 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.2, "rate_lower": 9.4, "rate_upper": 13 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 (SMC coverage level; Figure 5 note: analysis restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "during/post-SMC months (Jul-Dec), SMC coverage 80%", "estimate": { "measure": "incidence rate ratio", "value": 0.88, "lower": 0.62, "upper": 1.14, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.2, "rate_lower": 7.2, "rate_upper": 11.1 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 10.5, "rate_lower": 8.3, "rate_upper": 12.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 (SMC coverage level; Figure 5 note: analysis restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "during/post-SMC months (Jul-Dec), SMC coverage 90%", "estimate": { "measure": "incidence rate ratio", "value": 0.95, "lower": 0.56, "upper": 1.35, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.3, "rate_lower": 6.5, "rate_upper": 12.1 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.7, "rate_lower": 6.9, "rate_upper": 12.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 (SMC coverage level; Figure 5 note: analysis restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "during/post-SMC months (Jul-Dec), SMC coverage 100%", "estimate": { "measure": "incidence rate ratio", "value": 1.04, "lower": 0.46, "upper": 1.62, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.4, "rate_lower": 5.7, "rate_upper": 13.2 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.1, "rate_lower": 5.5, "rate_upper": 12.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 (SMC coverage level; Figure 5 note: analysis restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "not stated", "subgroup": "clusters with SMC coverage below 80% (N=222)", "estimate": { "measure": "incidence rate ratio", "value": 0.73, "lower": 0.56, "upper": 0.96, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.9, "rate_lower": 7.3, "rate_upper": 10.5 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 12.1, "rate_lower": 9.6, "rate_upper": 14.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 4 and Results; pmid:41021553 Results (IRR only; S1 and S2 Tables not in sources)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "not stated", "subgroup": "clusters with SMC coverage 80% or above (N=86)", "estimate": { "measure": "incidence rate ratio", "value": 1.0, "lower": 0.59, "upper": 1.69, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.2, "rate_lower": 5.9, "rate_upper": 12.6 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.2, "rate_lower": 5.8, "rate_upper": 12.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 4 and Results; pmid:41021553 Results (IRR only; S1 and S2 Tables not in sources)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "not stated", "subgroup": "all clusters (N=285) in the SMC coverage 80% threshold analysis", "estimate": { "measure": "incidence rate ratio", "value": 0.78, "lower": 0.61, "upper": 0.99, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.0, "rate_lower": 7.5, "rate_upper": 10.4 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.5, "rate_lower": 9.4, "rate_upper": 13.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 4 'Across all clusters (N=285)'" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "children in households with pre-census data (15,291 households in 170 clusters), all wealth quintiles", "estimate": { "measure": "incidence rate ratio", "value": 0.83, "lower": 0.63, "upper": 1.1, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.9, "rate_lower": 7.3, "rate_upper": 10.5 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 10.7, "rate_lower": 8.3, "rate_upper": 13.1 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4; pmid:40630579 Table 4 (same numbers), 'Across quintiles' row at household and cluster level; Results text of both" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "pre-census households, household-level wealth index quintile 1st (least wealthy)", "estimate": { "measure": "incidence rate ratio", "value": 0.88, "lower": 0.53, "upper": 1.24, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.5, "rate_lower": 8.6, "rate_upper": 14.3 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 13.0, "rate_lower": 8.8, "rate_upper": 17.1 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4; pmid:40630579 Table 4 (same numbers)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "pre-census households, household-level wealth index quintile 2nd", "estimate": { "measure": "incidence rate ratio", "value": 0.86, "lower": 0.58, "upper": 1.13, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 10.0, "rate_lower": 8.0, "rate_upper": 12.0 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.7, "rate_lower": 8.7, "rate_upper": 14.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4; pmid:40630579 Table 4 (same numbers)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "pre-census households, household-level wealth index quintile 3rd", "estimate": { "measure": "incidence rate ratio", "value": 0.83, "lower": 0.59, "upper": 1.06, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.7, "rate_lower": 7.2, "rate_upper": 10.2 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 10.6, "rate_lower": 8.2, "rate_upper": 12.9 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4; pmid:40630579 Table 4 (same numbers)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "pre-census households, household-level wealth index quintile 4th", "estimate": { "measure": "incidence rate ratio", "value": 0.8, "lower": 0.56, "upper": 1.04, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 7.6, "rate_lower": 6.2, "rate_upper": 9.1 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.5, "rate_lower": 7.4, "rate_upper": 11.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4; pmid:40630579 Table 4 (same numbers)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "pre-census households, household-level wealth index quintile 5th (wealthiest)", "estimate": { "measure": "incidence rate ratio", "value": 0.77, "lower": 0.5, "upper": 1.05, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 6.7, "rate_lower": 5.1, "rate_upper": 8.2 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.6, "rate_lower": 6.3, "rate_upper": 10.9 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4; pmid:40630579 Table 4 (same numbers)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "pre-census households, cluster-level wealth index quintile 1st (least wealthy)", "estimate": { "measure": "incidence rate ratio", "value": 0.8, "lower": 0.43, "upper": 1.17, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.9, "rate_lower": 8.2, "rate_upper": 15.6 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 14.9, "rate_lower": 9.8, "rate_upper": 20 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4; pmid:40630579 Table 4 (same numbers)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "pre-census households, cluster-level wealth index quintile 2nd", "estimate": { "measure": "incidence rate ratio", "value": 0.79, "lower": 0.53, "upper": 1.05, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 10.0, "rate_lower": 7.8, "rate_upper": 12.1 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 12.7, "rate_lower": 9.5, "rate_upper": 15.8 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4; pmid:40630579 Table 4 (same numbers)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "pre-census households, cluster-level wealth index quintile 3rd", "estimate": { "measure": "incidence rate ratio", "value": 0.78, "lower": 0.57, "upper": 0.99, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.4, "rate_lower": 7, "rate_upper": 9.7 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 10.8, "rate_lower": 8.4, "rate_upper": 13.1 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4; pmid:40630579 Table 4 (same numbers)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "pre-census households, cluster-level wealth index quintile 4th", "estimate": { "measure": "incidence rate ratio", "value": 0.77, "lower": 0.51, "upper": 1.02, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 7.0, "rate_lower": 5.7, "rate_upper": 8.3 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.2, "rate_lower": 6.7, "rate_upper": 11.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4; pmid:40630579 Table 4 (same numbers)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "pre-census households, cluster-level wealth index quintile 5th (wealthiest)", "estimate": { "measure": "incidence rate ratio", "value": 0.75, "lower": 0.4, "upper": 1.11, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 5.9, "rate_lower": 4.2, "rate_upper": 7.5 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 7.8, "rate_lower": 4.9, "rate_upper": 10.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4; pmid:40630579 Table 4 (same numbers)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "6-59 months", "period": "whole", "subgroup": "MUAC ≥ 12.5 cm (no acute malnutrition)", "estimate": { "measure": "incidence rate ratio", "value": 0.84, "lower": 0.68, "upper": 1.06, "level": 0.95 }, "treated": { "deaths": 432, "person_years": 56215, "children": null, "rate_per_1000_person_years": 7.7, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 496, "person_years": 54287, "children": null, "rate_per_1000_person_years": 9.1, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:39466816 Table 2 and Results" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "6-59 months", "period": "whole", "subgroup": "MUAC < 12.5 cm (acute malnutrition)", "estimate": { "measure": "incidence rate ratio", "value": 0.49, "lower": 0.25, "upper": 0.99, "level": 0.95 }, "treated": { "deaths": 16, "person_years": 942, "children": null, "rate_per_1000_person_years": 17.3, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 32, "person_years": 904, "children": null, "rate_per_1000_person_years": 35.4, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:39466816 Table 2 and Results" } ], "deaths_ascertainment": "Biannual census: 'All-cause mortality as determined by biannual census among children aged 1-59 months' (NCT03676764); 'An enumerative census was conducted during each twice-yearly distribution, during which vital status for all children in the community was collected' (ppr:PPR1068494). Person-time was summed over intercensal periods, children alive at both censuses contributing that period, and a cluster not censused (eg, due to security) could reenter at a later census (NCT03676764). 68 246 children contributed 119 139 person-years (pmid:38349371). Because of security concerns only 284 of 341 randomized communities entered the first census; 146 azithromycin and 139 placebo communities contributed person-time, 56 communities none (pmid:41252743). The number of communities and children lost to follow-up due to security concerns 'was similar between treatment groups' (counts only in Figures 1 and 2); census status 'moved' 10.6% vs 9.6% and 'unknown' 0.3% vs 0.2%, azithromycin vs placebo (pmid:38349371). Verbal autopsies were available for 456 (91.6%) azithromycin and 536 (91.2%) placebo deaths (pmid:41252743).", "coverage": "A mean (SD) of 90.1% (16.0%) of the censused children received the scheduled study drug in the azithromycin group and 89.8% (17.1%) in the placebo group (pmid:38349371; eTable 1). 'The overall coverage of MDA was approximately 90% for both AZ and placebo arms' (pmid:41662252).", "notes": "Whole-trial IRR printed with two intervals: 0.82 (0.67-1.02) in the main report (pmid:38349371) and 0.82 (0.66 to 1.01) in Table 2 'Overall (Jan-Dec)' of the SMC secondary analysis (pmid:41021553, preprint pmid:40343013); both entered. The main report's Figure 3 footnote gives a permutation P value (10 000 replicates, log IRR as test statistic) but its Results do not say how the intervals were computed, so adjusted_for_clustering is null; the SMC and wealth reports' abstracts (ppr:PPR1012955, ppr:PPR1048111) describe Poisson regression with a person-time offset and robust standard errors, not said to account for community randomization (null). A nonprespecified covariate-adjusted sensitivity analysis 'led to nearly identical results' (eTable 3; no numbers printed). SMC report: its sensitivity analysis adjusting for coverage printed the same season IRRs (0.77 (0.6 to 0.98) SMC season, 0.89 (0.68 to 1.15) non-SMC season; S3 Table), not entered again; its analysis by quarter printed only a rate difference for October-December (IRD -4.0 per 1,000 person-years, 95% CI -7.9 to -0.11) and its lowest vs highest coverage quintile comparison (S4 Fig) no numbers. Season is entered as a subgroup with period 'whole'. Table 3 of pmid:40343013 gives the effect at SMC coverage levels 30% to 100%; the Figure 5 note says this analysis was restricted to July-December, and its 'Overall' row repeats the July-December IRR with slightly different arm rates than Table 2 (9.0 (7.5 to 10.4) and 11.6 (9.6 to 13.6) vs 9 (7.5 to 10.4) and 11.7 (9.5 to 13.9)), so both are entered. Table 4 (80% threshold) does not state its period; its across-all-clusters rates (9.0 and 11.5) are not the whole-year rates (8.2 and 10.0), so its period is entered as 'not stated'; its note says some clusters count in both coverage groups (222 + 86 vs 285). The published version (pmid:41021553) prints the threshold IRRs in its text only and has no Table 3 or 4. Wealth entries (pmid:41662252 and preprint pmid:40630579, same numbers) cover only children in the 15,291 pre-census households in 170 clusters; Table 4's note says wealth quintiles were entered in linear form and distance to facility was a covariate, so quintile IRRs come from that model; the 'Across quintiles' row is identical at household and cluster level and is entered once; a mixed-effects Poisson sensitivity analysis with a random cluster intercept is reported only for the interaction terms. Malnutrition entries (pmid:39466816) are for children 6-59 months by MUAC; that report says 297 clusters contributed person-time (145 azithromycin, 152 placebo) where others say 146 and 139; its Table 1 baseline counts with MUAC < 12.5 cm (1,020 azithromycin, 1,107 placebo) are not entered as children because the sources do not say they are the children whose person-time Table 2 counts; the rate difference for MUAC < 12.5 cm has upper limit -0.1 in the text and -0.01 in Table 2; Fig 3B (infants 1-11 months by WAZ) prints no numbers. Pooled-arm rates (eg 9.1 per 1,000 person-years overall) are not comparisons and are not entered. The registry's second primary outcome (individually randomized infants, 82 vs 75 deaths) belongs to the infant-visit trial (T05). Cause-specific results (pmid:41252743, ppr:PPR1068494) and nutrition results (pmid:42868154, ppr:PPR1068411) are not all-cause mortality and are not entered." }, { "trial": "T05", "entries": [ { "comparison": "Targeted oral azithromycin vs Targeted oral placebo", "ages": "infants treated at 5-12 weeks of age; deaths before 6 months of age", "period": "whole", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 1.09, "lower": 0.8, "upper": 1.49, "level": 0.95 }, "treated": { "deaths": 82, "person_years": null, "children": 16416, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 75, "person_years": null, "children": 16461, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:38231623 abstract (Results; 16,416 and 16,461 randomly assigned; primary end point death before 6 months of age); NCT03676764 adverse events module (deaths 82 of 16416 and 75 of 16461)" }, { "comparison": "Targeted oral azithromycin vs Targeted oral placebo", "ages": "individually randomized at 4-12 weeks of age (registry outcome title); time frame 6 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": 82, "person_years": null, "children": 15734, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 75, "person_years": null, "children": 15701, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "NCT03676764 posted results, primary outcome 'All-cause Mortality Rate in Individually Randomized Children at 4-12 Weeks of Age' (denominators 15734 and 15701; 82 and 75); pmid:39317182 Results and Table 1 (N = 15,734 and 15,701; 157 deaths included in the primary analysis)" } ], "deaths_ascertainment": "'Vital status was assessed at 6 months of age' (pmid:38231623); 'All-cause mortality as determined by a follow-up visit for individually randomized children at healthy child visits' (NCT03676764). Of 16,416 azithromycin and 16,461 placebo infants randomized, the registry's primary-outcome denominators are 15,734 and 15,701 (also pmid:39317182 Table 1); no count of children lost to follow-up is printed for mortality. Verbal autopsy results were available for 136 of 157 deaths (87%): 72 (88%) azithromycin, 64 (85%) placebo (pmid:39317182).", "coverage": null, "notes": "The two entries share the 82 and 75 deaths but print different denominators: the abstract's randomized groups (16,416 and 16,461, matching the registry's adverse events module) and the registry's primary-outcome participants (15,734 and 15,701); both entered. The registry titles the outcome for children 'at 4-12 Weeks of Age' while the abstract and the registry's group descriptions say 5 to 12 weeks; its measure is a count of participants though the title says rate. The abstract reports no evidence of an effect in prespecified subgroups (age, sex, baseline weight) without numbers, and an absolute difference in mortality of 0.04 percentage points (95% CI -0.10 to 0.21). A pooled analysis of infants at risk of poor growth and development in this trial and NAITRE (pmid:40779591) gives death by 6 months 63 (1.3%) azithromycin vs 52 (1.1%) placebo, OR 1.19 (0.82 to 1.72), N = 9,471 in analysis (4,792 and 4,627 included in mortality analyses), logistic regression with standard errors adjusted for clustering by study; it pools two trials, so it is not entered for this comparison. Cause-specific hazard ratios (pmid:39317182) and growth outcomes (pmid:38261579) are not all-cause mortality." }, { "trial": "T06", "entries": [ { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 0.85, "lower": 0.56, "upper": 1.28, "level": 0.95 }, "treated": { "deaths": 42, "person_years": null, "children": 9606, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 50, "person_years": null, "children": 9684, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:35692260 Results (Primary Outcome) and Table 2 'All participants'; NCT03682653 primary outcome '6 Month Mortality - All Cause' (9606 and 9684; 42 and 50)" }, { "comparison": "Azithromycin vs Placebo", "ages": "enrolled at 8 to 14 days of age", "period": "by 6 months of age", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 0.85, "lower": 0.53, "upper": 1.38, "level": 0.95 }, "treated": { "deaths": 31, "person_years": null, "children": 7207, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 37, "person_years": null, "children": 7347, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "enrolled at 15 to 21 days of age", "period": "by 6 months of age", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 0.6, "lower": 0.2, "upper": 1.82, "level": 0.95 }, "treated": { "deaths": 5, "person_years": null, "children": 1634, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 8, "person_years": null, "children": 1562, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "enrolled at 22 to 28 days of age", "period": "by 6 months of age", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 1.22, "lower": 0.37, "upper": 3.98, "level": 0.95 }, "treated": { "deaths": 6, "person_years": null, "children": 765, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 5, "person_years": null, "children": 774, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "female", "estimate": { "measure": "hazard ratio", "value": 0.92, "lower": 0.5, "upper": 1.68, "level": 0.95 }, "treated": { "deaths": 20, "person_years": null, "children": 4748, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 22, "person_years": null, "children": 4786, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "male", "estimate": { "measure": "hazard ratio", "value": 0.79, "lower": 0.45, "upper": 1.38, "level": 0.95 }, "treated": { "deaths": 22, "person_years": null, "children": 4858, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 28, "person_years": null, "children": 4898, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "enrolled in the rainy season (June-October)", "estimate": { "measure": "hazard ratio", "value": 0.68, "lower": 0.36, "upper": 1.28, "level": 0.95 }, "treated": { "deaths": 16, "person_years": null, "children": 4667, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 24, "person_years": null, "children": 4757, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "enrolled in the dry season (November-May)", "estimate": { "measure": "hazard ratio", "value": 1.0, "lower": 0.58, "upper": 1.72, "level": 0.95 }, "treated": { "deaths": 26, "person_years": null, "children": 4939, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 26, "person_years": null, "children": 4927, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "region: Centre", "estimate": { "measure": "hazard ratio", "value": 0.83, "lower": 0.22, "upper": 3.08, "level": 0.95 }, "treated": { "deaths": 4, "person_years": null, "children": 874, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 5, "person_years": null, "children": 904, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "region: Boucle du Mouhoun", "estimate": { "measure": "hazard ratio", "value": 0.35, "lower": 0.07, "upper": 1.72, "level": 0.95 }, "treated": { "deaths": 2, "person_years": null, "children": 1009, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 6, "person_years": null, "children": 1055, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "region: Cascade", "estimate": { "measure": "hazard ratio", "value": 1.06, "lower": 0.5, "upper": 2.26, "level": 0.95 }, "treated": { "deaths": 14, "person_years": null, "children": 1792, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 13, "person_years": null, "children": 1766, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "region: Centre Ouest", "estimate": { "measure": "hazard ratio", "value": 0.99, "lower": 0.25, "upper": 3.95, "level": 0.95 }, "treated": { "deaths": 4, "person_years": null, "children": 1062, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 4, "person_years": null, "children": 1050, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "region: Hauts-Bassins", "estimate": { "measure": "hazard ratio", "value": 0.82, "lower": 0.44, "upper": 1.54, "level": 0.95 }, "treated": { "deaths": 18, "person_years": null, "children": 4869, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 22, "person_years": null, "children": 4908, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "urbanicity: urban", "estimate": { "measure": "hazard ratio", "value": 0.95, "lower": 0.58, "upper": 1.56, "level": 0.95 }, "treated": { "deaths": 30, "person_years": null, "children": 7239, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 32, "person_years": null, "children": 7333, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "urbanicity: rural", "estimate": { "measure": "hazard ratio", "value": 0.62, "lower": 0.27, "upper": 1.44, "level": 0.95 }, "treated": { "deaths": 9, "person_years": null, "children": 1698, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 14, "person_years": null, "children": 1653, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "urbanicity: peri-urban", "estimate": { "measure": "hazard ratio", "value": 0.78, "lower": 0.17, "upper": 3.48, "level": 0.95 }, "treated": { "deaths": 3, "person_years": null, "children": 663, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 4, "person_years": null, "children": 688, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2 (subgroup analyses for the primary outcome)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "before 28 days of age", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 1.51, "lower": 0.54, "upper": 4.24, "level": 0.95 }, "treated": { "deaths": 9, "person_years": null, "children": 10485, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 6, "person_years": null, "children": 10547, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 3 and Results (Other outcomes); NCT03682653 secondary outcome 'Neonatal Mortality' (time frame 28 days; 10485 and 10547; 9 and 6)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "3-month mortality", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 1.16, "lower": 0.64, "upper": 2.11, "level": 0.95 }, "treated": { "deaths": 23, "person_years": null, "children": 10273, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 20, "person_years": null, "children": 10356, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 3" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "within 28 days of treatment", "subgroup": null, "estimate": null, "treated": { "deaths": 16, "person_years": null, "children": 10898, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 8, "person_years": null, "children": 10934, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 4 (serious adverse events; risk difference only)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "whole", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 0.81, "lower": 0.56, "upper": 1.17, "level": 0.95 }, "treated": { "deaths": 52, "person_years": null, "children": 9534, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 64, "person_years": null, "children": 9563, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:36343592 Results and Table 2 '12-Month mortality' (by 12 months of age); NCT03682653 secondary outcomes '12 Month Mortality - All Cause' and 'Vital Status' (time frame 12 months; 9534 and 9563; 52 and 64)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "not stated (adverse events module)", "subgroup": null, "estimate": null, "treated": { "deaths": 52, "person_years": null, "children": 10898, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 64, "person_years": null, "children": 10934, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "NCT03682653 adverse events module, all-cause deaths by group (52 of 10898; 64 of 10934)" } ], "deaths_ascertainment": "Vital status at follow-up visits in prespecified windows: at 6 months, 9,606 (88%) azithromycin and 9,684 (89%) placebo infants were measured in the pre-specified 6-month visit window and included in the primary analysis, and 847 and 805 more measured out of window were included in a sensitivity analysis (96% of enrolled infants in each arm) (pmid:35692260). At 12 months, 19,097 infants (87%; 9,534 azithromycin, 9,563 placebo) had vital status measured in the prespecified window and 1,993 more outside it (96% overall with known vital status at 12 months of age) (pmid:36343592). Registry: 'Caregivers will be asked if the child is dead or alive at 365 days of life' (NCT03682653). Verbal autopsy results were available for 112 (97%) of the 116 deaths by 12 months.", "coverage": "'Five neonates allocated to placebo did not receive their allocated study medication due to not being receptive to taking the study medication' (pmid:35692260); no other shortfall in receipt is printed.", "notes": "Period labels: the registry (NCT03682653) lists 6-month all-cause mortality as the primary outcome and 12-month mortality and vital status at 365 days as secondary outcomes, and the 12-month report says vital status was measured in a prespecified window, so 12-month mortality is entered as 'whole' and the 6-month primary outcome by its printed period; if 12 months is instead read as later follow-up, that entry would be an extension. The adverse events module's deaths (52 of 10898, 64 of 10934) equal the 12-month deaths over the randomized group sizes; its period is not printed, so it is a separate entry. The 12-month report's text says 10,928 were randomized to placebo; Table 1 of both reports and the registry say 10,934. Sensitivity analyses including infants measured outside the visit windows 'did not change results' (Table S3; Supplemental Table 2), and no additional deaths were identified at 12 months; no numbers printed. Table S4 subgroups are not in the sources. The urbanicity of 15 children is unknown. Mortality within 28 days of treatment is reported only as a risk difference (0.08 percentage points, 95% CI -0.02 to 0.17), so its estimate is null. The 12-month report's '19% relative reduction' restates HR 0.81. Table 2 of both reports gives permutation P values (10,000 replicates); how the intervals were computed is not stated. Age-at-enrollment subgroups are entered as age bands; Table 2 prints the last band as 22 to 28 days. The low birthweight and underweight report (pmid:37186577) prints no azithromycin-vs-placebo mortality numbers in its text (S1 Table; P for interaction 0.86); its Table 2 compares nutritional subgroups, not arms. The pooled at-risk analysis with CHATON (pmid:40779591; OR 1.19, 0.82 to 1.72) pools two trials and is not entered (see T05 notes). Cause-specific hazard ratios (pmid:36343592 Table 3) are not all-cause." }, { "trial": "T09", "entries": [ { "comparison": "biannual vs annual", "ages": "6 months to <5 years", "period": "whole", "subgroup": null, "estimate": { "measure": "rate ratio", "value": 0.81, "lower": 0.66, "upper": 1.0, "level": 0.95 }, "treated": { "deaths": 173, "person_years": null, "children": null, "rate_per_1000_person_years": 28.9, "rate_lower": 24.8, "rate_upper": 33.6 }, "control": { "deaths": 231, "person_years": null, "children": null, "rate_per_1000_person_years": 35.3, "rate_lower": 30.9, "rate_upper": 40.2 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:29561511 Results text (rates and rate ratio, citing Table 3)" }, { "comparison": "biannual vs annual", "ages": "6 months to <5 years", "period": "whole", "subgroup": null, "estimate": { "measure": "rate ratio", "value": 0.81, "lower": 0.66, "upper": 1.0, "level": 0.95 }, "treated": { "deaths": 173, "person_years": null, "children": null, "rate_per_1000_person_years": 29.0, "rate_lower": 24.8, "rate_upper": 33.8 }, "control": { "deaths": 231, "person_years": null, "children": null, "rate_per_1000_person_years": 35.6, "rate_lower": 30.9, "rate_upper": 40.9 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:29561511 Table 3" }, { "comparison": "biannual vs annual", "ages": "<6 months", "period": "whole", "subgroup": null, "estimate": { "measure": "rate ratio", "value": 0.92, "lower": 0.62, "upper": 1.37, "level": 0.95 }, "treated": { "deaths": 66, "person_years": null, "children": null, "rate_per_1000_person_years": 76.3, "rate_lower": 57.8, "rate_upper": 100.9 }, "control": { "deaths": 71, "person_years": null, "children": null, "rate_per_1000_person_years": 83.0, "rate_lower": 62.8, "rate_upper": 109.6 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:29561511 Table 3" }, { "comparison": "biannual vs annual", "ages": "5 years to <12 years", "period": "whole", "subgroup": null, "estimate": { "measure": "rate ratio", "value": 0.82, "lower": 0.56, "upper": 1.22, "level": 0.95 }, "treated": { "deaths": 53, "person_years": null, "children": null, "rate_per_1000_person_years": 5.6, "rate_lower": 4.1, "rate_upper": 7.4 }, "control": { "deaths": 71, "person_years": null, "children": null, "rate_per_1000_person_years": 6.8, "rate_lower": 5.2, "rate_upper": 8.8 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:29561511 Table 3" }, { "comparison": "biannual vs annual", "ages": "≥15 years", "period": "whole", "subgroup": null, "estimate": { "measure": "rate ratio", "value": 0.86, "lower": 0.68, "upper": 1.08, "level": 0.95 }, "treated": { "deaths": 132, "person_years": null, "children": null, "rate_per_1000_person_years": 8.4, "rate_lower": 7.1, "rate_upper": 10.0 }, "control": { "deaths": 155, "person_years": null, "children": null, "rate_per_1000_person_years": 9.8, "rate_lower": 8.4, "rate_upper": 11.5 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:29561511 Table 3" }, { "comparison": "biannual vs annual", "ages": "6 months to <12 years", "period": "whole", "subgroup": null, "estimate": { "measure": "rate ratio", "value": 0.82, "lower": 0.67, "upper": 0.99, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29561511 Results text (children combined into 1 age group)" } ], "deaths_ascertainment": "The Results do not say how deaths were recorded; the 48 communities were monitored from May 2010 until September 2013 and 'no communities were lost to follow-up'. Among children 6 months to less than 5 years, 497 (18.2%) in the annual arm and 567 (22.1%) in the biannual arm moved out of the study area or were lost to follow-up, with no significant difference by arm. Verbal autopsy was available for 362 (89.6%) of the 404 deaths in children 6 months to less than 5 years (pmid:29561511).", "coverage": "Average antibiotic treatment coverage of children 6 months to <5 years, mean (95% CI) by months after study initiation (pmid:29561511 Table 2). Annual arm: 0 months 92.3% (90.3%-94.1%), 12 months 89.2% (86.9%-91.3%), 24 months 90.1% (88.1%-91.9%), 36 months 84.7% (81.2%-88.1%). Biannual arm: 0 months 88.4% (84.8%-91.8%), 6 months 85.3% (81.8%-88.6%), 12 months 87.7% (84.7%-90.6%), 18 months 87.3% (83.3%-90.5%), 24 months 87.2% (84.4%-89.4%), 30 months 84.1% (80.6%-87.4%), 36 months 84.6% (81.0%-88.2%). 'The average treatment coverage of children 6 months to less than 5 years of age was greater than 80% across all treatment periods in both arms.'", "notes": "The text and Table 3 print different arm rates for children 6 months to <5 years (text: 35.3 (30.9 to 40.2) annual, 28.9 (24.8 to 33.6) biannual; Table 3: 35.6 (30.9-40.9) and 29.0 (24.8-33.8)) with the same rate ratio; both are entered. Table 3 is a 'Comparison of community-level mortality rates', its rate ratios and intervals from negative binomial regression and its P values from Monte Carlo permutation at the community level accounting for the stratified design, so adjusted_for_clustering is true for its entries and for the text entry citing it; the 6 months to <12 years estimate (P = 0.057) is in the text only, with no method stated. Mortality in children 6 months to <5 years is called 'a pre-specified outcome of the trial' (Table 3 footnote) in a report titled a secondary analysis, and the registry's primary outcomes are trachoma, so no entry is marked primary. Children younger than 6 months were offered tetracycline ointment instead of oral azithromycin in both arms. Table 3's oldest band is printed as '≥15 years old', with no band between 12 and 15 years. Children per arm are not printed (Table 1 gives mean participants per community). Table 2 lists annual-arm coverage at 0, 12, 24 and 36 months while the text names three annual distributions (June/July 2010, 2011, 2012). The registry (NCT00792922) posts only trachoma outcomes, and its adverse events module lists deaths as 'None of None'. The infectious-disease mortality rate ratio (0.73, 0.57 to 0.94) is not all-cause." }, { "trial": "T10", "entries": [ { "comparison": "arms A, B, and C together vs arm D (delayed treatment)", "ages": "1-9 years", "period": "whole", "subgroup": null, "estimate": { "measure": "odds ratio", "value": 0.51, "lower": 0.29, "upper": 0.9, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 4.1, "rate_lower": 3.0, "rate_upper": 5.7 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.3, "rate_lower": 5.3, "rate_upper": 13.1 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:19724043 abstract (Results; 'clustered logistic regression'; mortality over 1 year, May 2006 to May 2007)" } ], "deaths_ascertainment": "'Mortality was measured by enumerative census at baseline and again after 1 year' (pmid:19724043); losses to follow-up for the trial comparison are not printed. In the cohort report, a census 26 months after the baseline distribution found 320 deaths among individuals present at baseline treatment, and 2083 persons who had received antibiotics and 674 who had not moved away and were lost to follow-up (pmid:21427395). The adult report counts deaths 'By the 12-month census' (pmid:23545893).", "coverage": "'Antibiotic coverage levels for children aged 1 to 9 years exceeded 80% at all visits' (pmid:19724043). In arms A and B, 11 977 of 14115 persons (84.9%) aged 10 to 29 years and 7252 of 8217 (88.3%) aged 30 years or older received azithromycin; in arms C and D, 757 of 13996 (5.4%) and 109 of 8320 (1.3%) mistakenly received it (pmid:23545893). In the cohort report's 24 subkebeles, 31,133 (88.8%) of cohort members aged 1 year or older and 4914 children 1-5 years (89.2%) received azithromycin at baseline (pmid:21427395).", "notes": "The sources print no estimate for arm A, B, or C separately against arm D; the only entry is the intervention vs control comparison in the main abstract ('the intervention communities ... compared with the control group'). The abstract calls community-specific mortality risk for children 1 to 9 years the 'main outcome measure' of the report and 'a prespecified outcome for the clinical trial', not the trial's primary outcome, so primary is false. Arm sizes in the abstract (annual 15,902, biannual 17,288, quarterly 14,716, control 18,498 participants) count all residents, not children 1 to 9 years, so children is null. The cohort report (pmid:21427395) compares individuals who did and did not receive azithromycin within treated communities, not randomized arms (eg children 1-5 years: 29 vs 10 deaths, 2.79 vs 8.18 per 1000 person-years, OR 0.35 (0.17-0.74); within-household conditional logistic regression OR 0.40 (0.16-0.96)); not entered. The adult report (pmid:23545893) compares arms A+B with C+D, not a listed comparison: ages 10-29 years 1.42 (0.91-2.20) [19] vs 2.04 (1.30-3.23) [28], OR 0.69 (0.37-1.29); 30 years or older 9.69 (7.19-13.1) [79] vs 10.7 (8.71-13.3) [87], OR 0.89 (0.62-1.29) in its table but 0.91 (0.63-1.30) in its text; not entered." }, { "trial": "T12", "entries": [], "deaths_ascertainment": "No mortality result is printed; for the composite primary end point 'Data were recorded by means of active and passive surveillance' (pmid:30699301).", "coverage": "Overall, 30 629 (98.9%) of 30 977 study children received at least 1 dose of study medication; adherence to the SMC schedule was similar between groups (>65% received all 4 monthly cycles each year, >84% at least 3 cycles), and adherence to the 3-day regimen was >91% at all SMC contacts (pmid:33417683). Shares per arm are not printed.", "notes": "No all-cause mortality result is printed. The main report's primary end point is the composite of death or hospital admission for at least 24 hours not due to trauma or elective surgery (250 vs 238 events; 24.8 vs 23.5 per 1000 child-years at risk; incidence rate ratio 1.1, 95% CI 0.88 to 1.3; similar per protocol), and the secondary report (pmid:33417683) gives the same composite by time since the last SMC course (151 vs 170 events; rate ratios by stratum, Table 2). Deaths are not reported separately, so the trial has no entries." }, { "trial": "T13", "entries": [], "deaths_ascertainment": "No results; the protocol abstract says the primary outcome is 'assessed through mortality surveillance' (ppr:PPR918006).", "coverage": null, "notes": "The only source is the trial protocol's abstract (ppr:PPR918006), which prints no results. Its planned primary outcome is the all-cause mortality rate at 18 months of age, so the trial has no entries." } ]