Table 4 Safety results
System organ class (SOC) | Chloroquine-azithromycin (CQ/AZ) (N = 15) | Chloroquine (CQ) (N = 8) | All subjects (N = 23) | |||
|---|---|---|---|---|---|---|
Subjects | Subjects | Subjects | ||||
Preferred term (PT) | Events | n (%) | Events | n (%) | Events | n (%) |
Any treatment-related AE p = 0.2969 | 35 | 13 (86.7%) | 8 | 5 (62.5%) | 43 | 18 (78.3%) |
Gastrointestinal disorders p = 0.0713 | 28 | 12 (80.0%) | 4 | 3 (37.5%) | 32 | 15 (65.2%) |
 Nausea | 16 | 9 (60.0%) | 1 | 1 (12.5%) | 17 | 10 (43.5%) |
 Diarrhoea | 10 | 8 (53.3%) | 1 | 1 (12.5%) | 11 | 9 (9.1%) |
 Abdominal pain | 1 | 1 (6.7%) | 1 | 1 (12.5%) | 2 | 2 (8.7%) |
 Constipation | 0 | 0 | 1 | 1 (12.5%) | 1 | 1 (4.3%) |
 Vomiting | 1 | 1 (6.7%) | 0 | 0 | 1 | 1 (4.3%) |
General disorders | 2 | 1 (6.7%) | 1 | 1 (12.5%) | 3 | 2 (8.7%) |
 Fatigue | 2 | 1 (6.7%) | 1 | 1 (12.5%) | 3 | 2 (8.7%) |
 Infections and infestations | 2 | 2 (13.3%) | 1 | 1 (12.5%) | 3 | 3 (13.0%) |
 Vulvovaginal mycotic infections | 2 | 2 (13.3%) | 1 | 1 (12.5%) | 3 | 3 (13.0%) |
Skin and subcutaneous tissue disorders | 3 | 3 (20.0%) | 2 | 2 (25.0%) | 5 | 5 (21.7%) |
 Pruritus | 3 | 3 (20.0%) | 2 | 2 (25.0%) | 5 | 5 (21.7%) |