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. 2015 Jun 24;6(19):17031–17038. doi: 10.18632/oncotarget.4400

Table 1. Association between Defined Daily Dose and hepatic adverse drug reactions.

DDD Group (Drug Number) DDD < 10 mg (n = 169) 10 ≤ DDD < 100 mg (n = 288) DDD ≥ 100 mg (n = 518) P-value
hADRs Type
Fatal hADRs 12 (7%) 35 (12%) 103 (20%) 1.31E-05***
Liver Failure 13 (8%) 58 (20%) 137 (26%) 3.42E-07***
Liver Transplantation 1 (1%) 8 (3%) 28 (5%) 2.41E-03**
Jaundice 36 (21%) 83 (29%) 190 (37%) 8.43E-05***
Biomarker Increase 23 (14%) 67 (23%) 161 (31%) 3.43E-06***
Hepatomegaly 6 (4%) 12 (4%) 43 (8%) 8.29E-03**
Hepatitis 27 (16%) 74 (26%) 190 (37%) 5.94E-08***
Severe hADRs 16 (9%) 60 (21%) 149 (29%) 1.53E-07***
All hADRs 60 (36%) 130 (45%) 288 (56%) 1.60E-06***

P value was determined using the Cochran-Armitage test.

*

P < 0.05

**

P < 0.01

***

P < 0.001