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Table 2 Summary of studies comparing CQ+SP, AQ+SP, and AS+AQ demonstrating variability between study sites

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      
   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
  1. * At UMSP sites (Jinja, Arua, Tororo, Apac), data on relationship was collected only for adverse events of moderate or greater severity