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Table. 10.

Table. 10.

Comparisons of safety in therapeutic drug monitoring (TDM) vs. non-TDM groups

TDM (n = 27)non-TDM (n = 27)Total (n = 54)p-value
Cytopenia, N(%)
 Leukopenia7 (25.9)6 (22.2)13 (24.1)0.750a
 Neutropenia1 (3.7)4 (14.8)5 (9.3)0.351a
 Anemia2 (7.4)3 (11.1)5 (9.3)1.000a
 Thrombocytopenia2 (7.4)7 (25.9)9 (16.7)0.142a
Liver function
 ΔAST, IU/L77.0 [11.0-2192.0]30.0 [2.0-817.0]60.0 [2.0-2192.0]0.046b
 ΔALT, IU/L58.0 [1.0-1293.0]26.0 [0.0-165.0]44.0 [0.0-1293.0]0.077b
 ΔT.bil, mg/dL0.3 [0.0-21.3]0.1 [0.0-21.3]0.2 [0.0-21.3]0.394b
Renal function
 ΔBUN, mg/dL24.7 [3.5-67.6]14.2 [0.0-99.1]19.4 [0.0-99.1]0.026b
 ΔsCr, g/dL0.6 [0.0-3.6]0.2 [0.0-3.1]0.4 [0.0-3.6]0.002b
Heart dysfunction, N(%)
 Tachycardia3 (11.1)4 (14.8)7 (13.0)1.000a
 Bradycardia0 (0.0)0 (0.0)0 (0.0)1.000a
 Prolonged QT interval1 (3.7)0 (0.0)1 (1.9)1.000a
Electrolyte imbalance, mEq/L
 ΔSerum Na increase7.7 ± 4.46.1 ± 4.96.9 ± 4.60.204b
 ΔSerum Na decrease7.7 ± 5.86.1 ± 5.56.8 ± 5.60.378b
 ΔSerum K increase1.5 [0.5-4.8]1.1 [0.0-3.3]1.3 [0.0-4.8]0.021b
 ΔSerum K decrease1.0 ± 0.60.9 ± 0.71.0 ± 0.70.935b
 ΔSerum Ca increase1.2 [0.0-2.8]0.7 [0.0-2.8]1.1 [0.0-2.8]0.076b
 ΔSerum Ca decrease0.9 ± 0.71.0 ± 1.00.9 ± 0.80.709b
Skin rash, N(%)1 (3.7)3 (11.1)4 (7.4)0.610a
Visual disturbance, N(%)2 (7.4)2 (7.4)4 (7.4)1.000a

Data are No. (%), mean ± SD or median [min-max]

From the Chi-square test or Fisher’s exact test

From the Independent t-test or Mann-Whitney U test

AST, aspartate aminotransferase; ALT, alanine aminotransferase; T.bil, total bilirubin; BUN, blood urea nitrogen; sCr, serum creatinine

Korean J Clin Pharm 2019;29:89-100 https://doi.org/10.24304/kjcp.2019.29.2.89
© 2019 Korean J Clin Pharm