Safety outcomes | Chemoprevention arm | Compliant with monthly DP a (n = 107) | |||
---|---|---|---|---|---|
No chemoprevention (n = 992) | Monthly SP (n = 901) | Daily TS (n = 721) | Monthly DP (n = 444) | ||
Common adverse events of any severity, n (%) | |||||
Cough | 498 (50.2%) | 403 (44.7%) | 314 (43.6%)b | 203 (47.7%) | 53 (49.5%) |
Elevated temperature | 320 (32.3%) | 259 (28.8%) | 222 (30.8%) | 129 (29.1%) | 31 (29.0%) |
Diarrhoea | 286 (28.8%) | 192 (21.3%)b | 163 (22.6%)b | 95 (21.4%)b | 26 (24.3%) |
Pallor | 176 (17.7%) | 171 (19.0%) | 125 (17.3%) | 61 (13.7%) | 19 (17.8%) |
Vomiting | 134 (13.5%) | 82 (9.1%)b | 82 (11.4%) | 45 (10.1%) | 15 (14.0%) |
Anorexia | 64 (6.5%) | 67 (7.4%) | 27 (3.7%)b | 30 (6.8%) | 13 (12.2%) |
Any grade 3–4 adverse events, n (%) | 87 (8.8%) | 95 (10.5%) | 52 (7.2%) | 38 (8.6%) | 13 (12.2%) |
Any serious adverse events, n (%) | 20 (2.0%) | 26 (2.9%) | 14 (1.9%) | 7 (1.6%) | 2 (1.9%) |