From: Monitoring antimalarial safety and tolerability in clinical trials: A case study from Uganda
Trial | Kampala 1 | UMSP 2 | |||
---|---|---|---|---|---|
Study site | Kampala | Jinja | Arua | Tororo | Apac |
Total participants enrolled | 400 | 543 | 534 | 541 | 542 |
Median age years (IQR) | 4.2 (+/- 4.6) | 3.6 (+/- 5.5) | 1.5 (+/- 1.4) | 1.3 (+/- 1.5) | 1.8 (+/- 1.9) |
Age < 5 years | 221 (55%) | 332 (61%) | 497 (93%) | 500 (92%) | 489 (90%) |
Mean Hb Day 0 (SD) | 10.2 (1.9) | 10.6 (2.3) | 9.3 (1.7) | 9.0 (1.9) | 9.3 (1.9) |
Medications taken in past 2 weeks | 167 (41%) | 322 (59%) | 83 (16%) | 212 (39%) | 196 (36%) |
≥ 3 Additional medications prescribed | N/A | 100/543 (18%) | 150/534 (28%) | 385/541 (71%) | 50/542 (9%) |
Risk of clinical treatment failure | Â | Â | Â | Â | Â |
   CQ+SP | 59/126 (47%) | 128/160 (46%) | 50/178 (72%) | 116/162 (72%) | 52/180 (29%) |
   AQ+SP | 18/130 (14%) | 24/173 (14%) | 73/174 (42%) | 73/172 (42%) | 28/178 (16%) |
   AQ+AS | 16/130 (12%) | 24/181 (13%) | 62/171 (36%) | 93/181 (51%) | 46/172 (27%) |
Mean AEs (SD) per participant | 4.6 (3.3) | 2.5 (2.2) | 4.3 (2.2) | 5.8 (2.5) | 3.6 (2.2) |
Participants reporting AEs (%) | 371/396 (94) | 438/540 (81) | 521/534 (98) | 534/541 (99) | 522/541 (96) |
   CQ+SP | 127/131 (97) | 149/168 (89) | 174/180 (97) | 166/166 (100) | 181/185 (98) |
   AQ+SP | 120/132 (91) | 143/185 (77) | 176/180 (98) | 178/181 (98) | 175/182 (96) |
   AQ+AS | 124/133 (93) | 146/187 (78) | 171/174 (98) | 190/194 (98) | 166/174 (95) |
Total AEs by severity (%) | N = 1828 | N = 1348 | N = 2287 | N = 3117 | N = 1955 |
   Mild | 878 (48) | 756 (56) | 1736 (76) | 1462 (47) | 1322 (68) |
   Moderate | 898 (49) | 557 (41) | 529 (23) | 1622 (52) | 613 (31) |
   Severe | 48 (3) | 30 (2) | 21 (1) | 31 (1) | 20 (1) |
   Life-threatening | 4 (0.2) | 5 (0.4) | 1 (0.4) | 2 (0.1) | 0 |
Total AEs by relationship* (%) | N = 1828 | N = 554 | N = 551 | N = 1655 | N = 631 |
   Unlikely | 1129 (62) | 292 (53) | 424 (77) | 1159 (70) | 384 (61) |
   Possible | 480 (26) | 248 (45) | 127 (23) | 464 (28) | 238 (38) |
   Probable | 199 (11) | 14 (3) | 0 | 32 (2) | 9 (1) |
   Definite | 0 | 0 | 0 | 0 | 0 |