Table 3. AEs by treatment regimen and infection status.
| Drug Regimen | Mf Test Resultsa | Total Number of People Treated and Assessed for AEs and for Mf | Any AE n (%) |
Grade 1 n (%) |
Grade 2 n (%) |
Grade 3 n (%) |
Grade 4 n (%) | SAE n (%) |
|---|---|---|---|---|---|---|---|---|
| DA | Mf(−) | 11,262 | 1,287 (11.4) | 1,176 (10.4) | 99 (0.9) | 9 (0.1) | 0 (0.0) | 3 (0.0) |
| Mf(+) | 524 | 134 (25.6) | 124 (23.7) | 7 (1.3) | 1 (0.2) | 0 (0.0) | 2 (0.4) | |
| Total | 11,786 | 1,421 (12.1) | 1,300 (11.0) | 106 (0.9) | 10 (0.1) | 0 (0.0) | 5 (0.0) | |
| IDA | Mf(−) | 13,617 | 1,464 (10.8) | 1,340 (9.8) | 113 (0.8) | 10 (0.1) | 0 (0.0) | 1 (0.0) |
| Mf(+) | 612 | 241 (39.4) | 205 (33.5) | 35 (5.7) | 1 (0.2) | 0 (0.0) | 0 (0.0) | |
| Total | 14,229 | 1,705 (12.0) | 1,545 (10.9) | 148 (1.0) | 11 (0.1) | 0 (0.0) | 1 (0.0) |
AEs after IDA 12% versus 12.1% after DA, adjusted odds ratio for IDA versus DA 1.15, 95% CI 0.87–1.52, P = 0.316). See Statistical Methods for details.
aThis table does not include data for 17 persons with missing Mf values who were assessed for AEs after treatment.
Abbreviations: (−), negative results; (+), positive results; AE, adverse event; DA, double-drug therapy (diethylcarbamazine, albendazole); IDA, triple-drug therapy (ivermectin, diethylcarbamazine, albendazole); Mf, microfilaremia; SAE, serious AE.