Table 6 Day 7 DEAQ and LF blood concentrations by presence or absence of selected AEs, safety population, Study-T
Study-T | ASAQ | AL | ||||
|---|---|---|---|---|---|---|
(>5 years) | N = 496 | N = 502 | ||||
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 | 421/496 | 466 (352,606) | 447/502 | 505 (I 380,670) | ||
Fatigue (pool) | ||||||
No AE | 250/296 | 466 (352,605) | p = 0.925 | 376/421 | 504 (381,659) | p = 0.549 |
AE | 171/200 | 466 (352,606) | 71/81 | 519 (374,709) | ||
Vomiting | ||||||
No AE | 393/461 | 461 (345,603) | p = 0.003 | 440/494 | 505 (381,670) | p = 0.711 |
AE | 28/35 | 559 (467, 705) | 7/8 | 463 (277, 828) | ||
Nausea | ||||||
No AE | 407/480 | 466 (352, 605) | p = 0.754 | 443/497 | 505 (381, 670) | p = 0.111 |
AE | 14/16 | 457 (387, 648) | 4/5 | 245 (100, 549) | ||
Anaemia | ||||||
No AE | 350/422 | 462 (352, 604) | p = 0.162 | 403/453 | 505 (381, 701) | p = 0.745 |
AE | 71/74 | 517 (345, 677) | 44/49 | 508 (374, 616) | ||
Hepatotoxicity | ||||||
No AE | 402/473 | 465 (352, 606) | p = 0.512 | 418/471 | 506 (378, 681) | p = 0.882 |
AE | 19/23 | 485 (407, 586) | 29/31 | 477 (416, 659) | ||