Table 2 |
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|
Summary of studies comparing CQ+SP, AQ+SP, and AS+AQ demonstrating variability between study sites |
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|
Trial |
Kampala 1 |
UMSP 2 |
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|
|
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|
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%) |
|
|
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|
Risk of clinical treatment failure |
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|
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) |
|
|
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|
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) |
|
|
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|
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 |
|
|
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|
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 |
|
|
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|
* At UMSP sites (Jinja, Arua, Tororo, Apac), data on relationship was collected only for adverse events of moderate or greater severity |
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|
Staedke et al. Malaria Journal 2008 7:107 doi:10.1186/1475-2875-7-107 |
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