Table 4. Predicting hepatic adverse drug reactions using the combination of Defined Daily Dose, liver metabolism or LogP.
| Criteria | hADRs | OR (95% CI) | TPR | FPR | |||
|---|---|---|---|---|---|---|---|
| Y | N | ||||||
| Fatal hADRs | DDD ≥ 100 mg | Y | 103 | 415 | 2.17*** (1.47–3.21) |
69% | 50% |
| N | 47 | 410 | |||||
| DDD ≥ 100 mg & LogP ≥ 3 | Y | 44 | 117 | 2.46*** (1.60–3.73) |
30% | 15% | |
| N | 105 | 686 | |||||
| DDD ≥ 100 mg & LM ≥ 50% | Y | 66 | 171 | 2.70*** (1.76–4.15) |
56% | 32% | |
| N | 51 | 357 | |||||
| Liver Failure | DDD ≥ 100 mg | Y | 137 | 381 | 1.95*** (1.40–2.73) |
66% | 50% |
| N | 71 | 386 | |||||
| DDD ≥ 100 mg & LogP ≥ 3 | Y | 55 | 106 | 2.18*** (1.47–3.20) |
27% | 14% | |
| N | 152 | 639 | |||||
| DDD ≥ 100 mg & LM ≥ 50% | Y | 75 | 162 | 1.76** (1.20–2.57) |
47% | 33% | |
| N | 85 | 323 | |||||
| Liver Transplantation | DDD ≥ 100 mg | Y | 28 | 490 | 2.84** (1.28–6.92) |
76% | 52% |
| N | 9 | 448 | |||||
| DDD ≥ 100 mg & LogP ≥ 3 | Y | 15 | 146 | 3.59*** (1.69–7.43) |
41% | 16% | |
| N | 22 | 769 | |||||
| DDD ≥ 100 mg & LM ≥ 50% | Y | 13 | 224 | 1.76 (0.74–4.20) |
50% | 36% | |
| N | 13 | 395 | |||||
| Jaundice | DDD ≥ 100 mg | Y | 190 | 328 | 1.65*** (1.24–2.19) |
61% | 49% |
| N | 119 | 338 | |||||
| DDD ≥ 100 mg & LogP ≥ 3 | Y | 79 | 82 | 2.36*** (1.65–3.39) |
26% | 13% | |
| N | 229 | 562 | |||||
| DDD ≥ 100 mg & LM ≥ 50% | Y | 117 | 120 | 2.29*** (1.62–3.23) |
49% | 30% | |
| N | 122 | 286 | |||||
| Biomarker Increase | DDD ≥ 100 mg | Y | 161 | 357 | 1.84*** (1.35–2.50) |
64% | 49% |
| N | 90 | 367 | |||||
| DDD ≥ 100 mg & LogP ≥ 3 | Y | 61 | 100 | 1.96*** (1.34–2.84) |
24% | 14% | |
| N | 188 | 603 | |||||
| DDD ≥ 100 mg & LM ≥ 50% | Y | 98 | 139 | 2.01*** (1.41–2.86) |
48% | 32% | |
| N | 106 | 302 | |||||
| Hepatomegaly | DDD ≥ 100 mg | Y | 43 | 475 | 2.21** (1.22–4.13) |
70% | 52% |
| N | 18 | 439 | |||||
| DDD ≥ 100 mg & LogP ≥ 3 | Y | 16 | 145 | 1.83 (0.94–3.41) |
26% | 16% | |
| N | 45 | 746 | |||||
| DDD ≥ 100 mg & LM ≥ 50% | Y | 23 | 214 | 1.80 (0.94–3.44) |
50% | 36% | |
| N | 23 | 385 | |||||
| Hepatitis | DDD ≥ 100 mg | Y | 190 | 328 | 2.04*** (1.52–2.74) |
65% | 48% |
| N | 101 | 356 | |||||
| DDD ≥ 100 mg & LogP ≥ 3 | Y | 71 | 90 | 2.06*** (1.43–2.96) |
24% | 14% | |
| N | 219 | 572 | |||||
| DDD ≥ 100 mg & LM ≥ 50% | Y | 108 | 129 | 2.58*** (1.81–3.68) |
52% | 30% | |
| N | 100 | 308 | |||||
| Severe hADRs | DDD ≥ 100 mg | Y | 149 | 369 | 2.02*** (1.47–2.80) |
66% | 49% |
| N | 76 | 381 | |||||
| DDD ≥ 100 mg & LogP ≥ 3 | Y | 57 | 104 | 2.05*** (1.39–2.99) |
25% | 14% | |
| N | 167 | 624 | |||||
| DDD ≥ 100 mg & LM ≥ 50% | Y | 83 | 154 | 1.93*** (1.33–2.80) |
48% | 33% | |
| N | 89 | 319 | |||||
| All hADRs | DDD ≥ 100 mg | Y | 288 | 230 | 1.76*** (1.35–2.29) |
60% | 46% |
| N | 190 | 267 | |||||
| DDD ≥ 100 mg & LogP ≥ 3 | Y | 102 | 59 | 1.95*** (1.35–2.81) |
22% | 12% | |
| N | 372 | 419 | |||||
| DDD ≥ 100 mg & LM ≥ 50% | Y | 157 | 80 | 2.19*** (1.55–3.09) |
45% | 27% | |
| N | 193 | 215 | |||||
P value was determined using the Fisher's exact test. Y, positive; N, negative; DDD, Defined Daily Dose; OR, odds ratio; CI, confidence interval; LM, liver metabolism; TPR, true positive rate; FPR, false positive rate.
*
P < 0.05
**
P < 0.01
***
P < 0.001