Table 2. Outcome Measures (Primary and Secondary), Intention to Treat Analyses.
| End point | Participants, No./person-years, No. | P value | HR (95% CI) | P value | ||
|---|---|---|---|---|---|---|
| AZM group (n = 173)a | Placebo group (n = 174)b | AMD (95% CI) | ||||
| Primary outcome, FEV1 z score at 48 wk, mean (SD) | −1.90 (0.90) | −1.95 (0.91) | 0.06 (−0.10 to 0.21) | .48 | NA | NA |
| Secondary outcomesc | ||||||
| Total episodes of ARE | 19/157 | 38/154 | NA | NA | 0.50 (0.27 to 0.93) | .03 |
| First ARE | 16/148 | 30/139 | NA | NA | 0.50 (0.27 to 0.92) | .03 |
| Death | 0/157 | 3/154 | NA | NA | NA | NA |
| All-cause hospitalization | 2/157 | 11/154 | NA | NA | 0.24 (0.06 to 1.07) | .06 |
| Salmonella typhi infection | 0/157 | 0/154 | NA | NA | NA | NA |
| Gastroenteritis | 1/157 | 2/154 | NA | NA | NA | NA |
| Malaria | 1/157 | 2/154 | NA | NA | NA | NA |
| Weight-for-age z score, mean (SD) | −2.15 (1.38) | −1.94 (1.27) | 0.03 (−0.08 to 0.14) | .56 | NA | NA |
Abbreviations: AMD, adjusted mean difference; ARE, acute respiratory exacerbation; AZM, azithromycin; FEV1, forced expiratory volume in 1 second; HR, hazard ratio; NA, not applicable.
a
Primary and secondary outcomes were assessed for 162 patients in the AZM group.
b
Primary and secondary outcomes were assessed for 146 patients in the placebo group.
c
Outcomes refer to number of participants per person-years of risk, unless stated otherwise. Formal comparison of trial groups was not undertaken if fewer than 10 events overall or no events in 1 trial group.