|
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)
| |
- * 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.
