Table 3 Safety and tolerability outcome
Adverse events | AS + AQ n (%) | AL n (%) | p-value |
|---|---|---|---|
Overall | 88 (40.0) | 87 (39.5) | 1.00 |
Specific AEs | |||
Abdominal pain | 18 (8.1) | 17 (7.7) | 1.00 |
Digestive (nausea, vomiting, anorexia, diarrhea) | 22 (10.0) | 22 (10.0) | 0.86 |
Cough and rhinitis | 23 (10.5) | 28 (12.7) | 0.55 |
Bronchitis | 12 (5.4) | 13 (5.9) | 1.00 |
Fever | 40 (18.2) | 47 (21.4) | 0.47 |
Headache | 16 (7.3) | 21 (9.5) | 0.49 |
Other events | 17 (7.7) | 12 (5.5) | 0.44 |
SAE of any cause | 1 (0.5) | 1 (0.5) | 1.00 |