Site 1 | Site 2 | |||||
---|---|---|---|---|---|---|
AL (N = 175) | AQAS (N = 172) | p-value* | AL (N = 165) | AQAS (N = 168) | p-value* | |
Any adverse event | ||||||
Caregiver reported | 6 (3.4%) | 27 (15.7%) | < 0.001 | 25 (15.2%) | 41 (24.4%) | 0.039 |
Specific adverse events | ||||||
Vomiting | 4 (2.3%) | 16 (9.3%) | 0.005 | 13 (7.9%) | 18 (10.7%) | 0.452 |
Weakness-Fatigue | 0 (0.0%) | 12 (7.0%) | < 0.001 | 9 (5.5%) | 29 (17.3%) | 0.001 |
Dizziness | 0 (0.0%) | 10 (5.8%) | 0.001 | 7 (4.2%) | 4 (2.4%) | 0.376 |
Diarrhoea | 1 (0.6%) | 3 (1.7%) | 0.369 | 2 (1.2%) | 2 (1.2%) | 1.000 |
Other gastrointestinal complaintsa | 1 (0.6%) | 5 (2.9%) | 0.119 | 2 (1.2%) | 4 (2.4%) | 0.685 |
Other AE reportedb | 1 (0.6%) | 2 (1.2%) | 0.621 | 4 (2.4%) | 4 (2.4%) | 1.000 |