Table 4. Adverse events by age-group, gender and treatment regimen.
| Treatment group | Gender | Age-class (Years) | No. assessed for AEs | No. with AE (%) | No. with Grade 1 AE (%) | No. with Grade 2 AE (%) | No. with Grade 3 AE (%) |
|---|---|---|---|---|---|---|---|
| IDA | Female | 5–17 | 804 | 45 (5.6) | 41 (5.1) | 4 (0.5) | 0 (0.00) |
| > = 18 | 1596 | 179 (11.2) | 158 (9.9) | 21 (1.3) | 0 (0.00) | ||
| Overall | 2400 | 224 (9.3) | 199 (8.3) | 25 (1.0) | 0 (0.00) | ||
| Male | 5–17 | 928 | 52 (5.6) | 48 (5.1) | 4 (0.4) | 0 (0.00) | |
| > = 18 | 1351 | 112 (8.3) | 104 (7.7) | 7 (0.5) | 1 (0.01) | ||
| Overall | 2278 | 164 (7.2) | 152 (6.7) | 11 (0.5) | 1 (0.04) | ||
| Both | 5–17 | 1732 | 97 (5.6) | 89 (5.1) | 8 (0.5) | 0 (0.00) | |
| > = 18 | 2947 | 291 (9.9) | 262 (8.9) | 28 (0.9) | 1(0.03) | ||
| Overall | 4679 | 388 (8.3) | 351 (7.5) | 36 (0.8) | 1 (0.02) | ||
| DA | Female | 5–17 | 743 | 41 (5.5) | 39 (5.2) | 2 (0.3) | 0 (0.00) |
| > = 18 | 1393 | 140 (10.1) | 137 (9.8) | 3 (0.2) | 0 (0.00) | ||
| Overall | 2136 | 181 (8.5) | 176 (8.2) | 5 (0.2) | 0 (0.00) | ||
| Male | 5–17 | 776 | 24 (3.1) | 24 (3.1) | 0 (0.0) | 0 (0.00) | |
| > = 18 | 1216 | 58 (4.8) | 57 (4.7) | 1 (0.1) | 0 (0.00) | ||
| Overall | 1992 | 82 (4.1) | 81 (4.1) | 1 (0.1) | 0 (0.00) | ||
| Both | 5–17 | 1519 | 65 (4.3) | 63 (4.1) | 2 (0.1) | 0 (0.00) | |
| > = 18 | 2609 | 198 (7.6) | 194 (7.4) | 4 (0.2) | 0 (0.00) | ||
| Overall | 4128 | 263 (6.4) | 257 (6.2) | 6 (0.1) | 0 (0.00) |
The overall AE rates and severity of AE differ by treatment regimens (P<0.01 for all comparisons).
In IDA and DA treatment areas, AE rates (Overall, Grade 1 and Grade2) were significantly different between females and males (p<0.05).
AE rates (overall and Grade 1) did not different significantly among females between IDA and DA treatment areas (P>0.05).
Grade 2 AE was significantly higher in IDA arm compared to DA arm (P<0.05).
AE rates (overall, grade 1 and grade 2) differ significantly between treatment areas among males (p<0.001).
AE rate significantly higher after IDA than after DA in adult (P = 0.003), but the difference was not significant for children (P = 0.084).