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) | ||