Table 7.
Day 7 DEAQ and LF blood concentrations by presence or absence of selected AEs, safety population, Study-E
|
Study-E |
ASAQ |
AL |
||||
|---|---|---|---|---|---|---|
|
(6–59 months) |
N = 149 |
N = 150 |
||||
| AEs of interest |
Patients |
DEAQ blood concentration |
p-value |
Patients |
LF blood concentration |
p-value |
| n/N* | [ng/ml] median (IQR) | ** | n/N* | [ng/ml] median (IQR) | ** | |
| All patients |
137/149 |
423 (314,602) |
|
139/150 |
310 (200,447) |
|
|
Fatigue (pool) | ||||||
| No AE |
93/105 |
396 (302,529) |
p = 0.004 |
122/130 |
332 (200,447) |
p = 0.332 |
| AE |
44/44 |
501 (354,794) |
|
17/20 |
256 (100,344) |
|
|
Vomiting | ||||||
| No AE |
122/133 |
435 (314,602) |
p = 0.725 |
130/140 |
313 (200,447) |
p = 0.428 |
| AE |
15/16 |
366 (277,743) |
|
9/10 |
256 (100,329) |
|
|
Nausea | ||||||
| No AE |
137/149 |
423 (314,602) |
na |
138/149 |
310 (200,447) |
na |
| AE |
0/0 |
- |
|
1/1 |
256 |
|
|
Anaemia | ||||||
| No AE |
105/115 |
423 (310,554) |
p = 0.455 |
116/127 |
305 (150,431) |
p = 0.030 |
| AE |
32/34 |
443 (332,739) |
|
23/23 |
380 (262,566) |
|
|
Hepatotoxicity | ||||||
| No AE |
125/136 |
416 (311,554) |
p = 0.065# |
121/132 |
329 (217,457) |
p = 0.049 |
| AE | 12/13 | 569 (354,934) | 18/18 | 150 (100,409) | ||
AE = adverse event; * n/N = number of blood samples available and quantifiable (n) among total patients with or without AE (N); ** Two-sample Wilcoxon rank-sum (Mann–Whitney) test; # When patients with deviations (quantifiable AQ on day 0 or day 7) were excluded from this comparative analysis (n = 6): p = 0.036.