Table 4.
SAEs in infants by treatment arm
| SAE by system organ class | AL (N = 822) | ASAQ (N = 775) | MQAS (N = 765) | DHAPQ (N = 765) | ||||
|---|---|---|---|---|---|---|---|---|
| % | n | % | n | % | n | % | n | |
| Congenital disorders | 2.1 | 17 | 1.5 | 12 | 1.6 | 12 | 0.8 | 6 |
| Infection and infestations | 1.5 | 12 | 1.5 | 12 | 0.9 | 7 | 2.0 | 15 |
| Respiratory disorders | 1.0 | 8 | 0.8 | 6 | 0.9 | 7 | 1.0 | 8 |
| General disorders | 0.6 | 5 | 0.4 | 3 | 0.8 | 6 | 1.0 | 8 |
| Gastrointestinal disorders | 0.4 | 3 | 0.0 | 0 | 0.3 | 2 | 0.0 | 0 |
| Perinatal complications | 0.4 | 3 | 0.5 | 4 | 0.1 | 1 | 0.9 | 7 |
| Blood disorders | 0.2 | 2 | 0.0 | 0 | 0.1 | 1 | 0.1 | 1 |
| Hepatobiliary disorders | 0.1 | 1 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 |
| Metabolism and nutrition disorders | 0.1 | 1 | 0.1 | 1 | 0.0 | 0 | 0.3 | 2 |
| Reproductive and breast disorders (e.g. labia enlarged) | 0.1 | 1 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 |
| Nervous system disorders | 0.0 | 0 | 0.1 | 1 | 0.1 | 1 | 0.1 | 1 |