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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