| Mean (SD) at week 0 | Mean (SD) change from baseline |
---|
Week 24 | Week 48 | Week 72 | Week 96 | Week 120 | Week 144 | Week 192 | Week 240 | Week 288 | EOT |
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Absolute neutrophil count, 106/L | 4826.2 (1920.5) | −8.5 (1413.9) | −31.3 (1397.3) | −92.2 (1411.7) | 46.2 (1564.6) | − 206.7 (1560.6) | − 342.5 (1681.6) | − 457.7 (1685.6) | − 370.5 (1518.7) | − 621.1 (1558.1) | − 115.7 (1694.4) |
Hemoglobin, g/L | 126.0 (14.3) | 0.9 (7.6) | 1.6 (8.7) | 2.7 (10.1) | 3.5 (10.0) | 4.7 (10.2) | 6.1 (11.2) | 5.2 (11.4) | 5.7 (11.5) | 4.9 (9.3) | 1.2 (9.9) |
Lymphocytes, 106/L | 1429.8 (555.9) | −81.3 (382.1) | −151.1 (388.5) | − 195.6 (398.1) | − 270.2 (408.0) | − 310.3 (470.1) | − 434.2 (437.2) | − 468.5 (458.8) | − 480.0 (484.8) | − 647.4 (501.2) | − 216.4 (442.2) |
Platelets, 109/L | 273.9 (71.0) | −7.1 (42.6) | −10.3 (44.9) | −13.4 (46.6) | −16.4 (53.5) | −17.3 (55.7) | −29.1 (57.6) | −24.7 (63.2) | −26.9 (61.0) | −17.9 (62.5) | 2.2 (50.1) |
LDL-C, mmol/L | 3.115 (0.858) | 0.052 (0.561) | 0.093 (0.631) | 0.102 (0.673) | 0.085 (0.708) | 0.065 (0.811) | 0.114 (0.854) | 0.186 (0.910) | 0.183 (0.772) | 0.378 (0.877) | 0.055 (0.734) |
HDL-C, mmol/L | 1.889 (0.547) | 0.074 (0.316) | 0.110 (0.294) | 0.143 (0.335) | 0.180 (0.340) | 0.273 (0.334) | 0.382 (0.334) | 0.327 (0.344) | 0.359 (0.298) | 0.486 (0.394) | 0.116 (0.352) |
Creatinine, μmol/L | 58.17 (14.55) | 1.09 (6.38) | 2.37 (6.42) | 2.91 (6.88) | 4.03 (7.05) | 5.16 (7.66) | 8.15 (7.21) | 7.93 (6.83) | 8.42 (7.07) | 7.96 (9.11) | 2.16 (8.19) |
Creatine kinase, U/L | 131.2 (124.8) | 3.0 (109.8) | 13.7 (120.4) | 20.5 (151.8) | 30.5 (105.5) | 41.0 (86.4) | 69.7 (66.4) | 82.4 (88.3) | 77.3 (84.6) | 93.1 (74.7) | 14.2 (132.5) |
ALT, U/L | 22.9 (16.5) | 0.7 (18.4) | 0.9 (14.0) | 1.3 (16.1) | 2.3 (15.7) | 2.0 (13.1) | 5.9 (14.3) | 3.9 (10.1) | 5.9 (12.7) | 5.7 (9.4) | 0.9 (16.4) |
AST, U/L | 27.1 (11.9) | 0.7 (15.3) | 1.3 (10.8) | 1.7 (11.5) | 2.2 (10.8) | 2.0 (9.7) | 5.0 (9.1) | 4.0 (8.0) | 5.2 (8.1) | 6.2 (7.1) | 1.3 (12.6) |
- EOT assessments and tests were to be performed promptly after the end of peficitinib administration; if peficitinib administration was terminated early, these assessments and tests were to be performed within 2 days of the last dose of peficitinib, if possible. As the timing of rollover from the previous study, and consequently the completion of the present trial, varied between individual patients, laboratory data at EOT were averaged regardless of the exact date of the EOT visit. ALT alanine aminotransferase, AST aspartate aminotransferase, EOT end of treatment, HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, SAF safety analysis set, SD standard deviation, Wk week