TABLE 3.
Multivariable analysis of levocarnitine prophylaxis and hepatotoxicity endpoints
| Covariable | Conjugated bilirubin >3 mg/dl | AST or ALT >10× ULN | ||||
|---|---|---|---|---|---|---|
| OR | 95% CI | p‐value a | OR | 95% CI | p‐value a | |
| Age | ||||||
| <15 years | Reference | Reference | ||||
| ≥15 years | 4.27 | 1.22–14.93 | 0.023 | 3.77 | 0.95–14.96 | 0.059 |
| BMI Category b | ||||||
| Not obese | Reference | Reference | ||||
| Obese | 6.14 | 1.88–20.05 | 0.003 | 5.02 | 1.25–20.18 | 0.023 |
| Ethnicity c | ||||||
| Not hispanic/Latinx | Reference | Reference | ||||
| Hispanic/Latinx | 0.72 | 0.21–2.51 | 0.603 | 0.27 | 0.07–1.10 | 0.069 |
| PEG‐ASP, # doses | ||||||
| One | Reference | Reference | ||||
| Two | 2.65 | 0.24–29.41 | 0.427 | 2.62 | 0.24–28.90 | 0.431 |
| Levocarnitine suppl. | ||||||
| No levocarnitine | Reference | Reference | ||||
| Prophylaxis | 0.13 | 0.02–0.81 | 0.029 | 0.34 | 0.07–1.73 | 0.194 |
Abbreviations: 95% CI, 95% Confidence IntervalBMI, body mass index; PEG‐ASP, pegylated asparaginase; ULN, upper limit of normal.
a
Logistic regression model, see methods; biologic sex was not significant in either model (p = 0.629 & p = 0.882, respectively).
b
Obesity defined according to population norms for BMI in patients <20 years old (BMI percentile <95% vs. ≥95% and BMI <30 vs. ≥30 in patients ≥20 years old).
c
Restricted to those with known ethnicity.