Table 1.
Causality assessment of adverse reactions to the DCA/ART combination treatment according to RUCAM (29, 30).
| Criterion | Observation | Given score | Score range |
|---|---|---|---|
| 1. Time to onset of the reaction | Toxic reaction 6 days after treatment | 2 | (+1 to +2) |
| 2. Course of the reaction | Decrease <50% within 30 days | 3 | (−2 to +3) |
| 3. Risk factors for drug reaction | Age of patient ≥55 years | 0 | (0 to +1) |
| 4. Concomitant drugs | No information | 0 | (−3 to 0) |
| 5. Non-drug-related causes | HAV, HBV, and HCV serology missing, no biliary obstruction, no alcoholism, no hypotension | 0 | (−3 to +2) |
| 6. Previous information on the drug | Hepatotoxicity published, but unlabeled | 1 | (0 to +2) |
| 7. Response to readministration | Not possible, because patient died | 0 | (−2 to +3) |
| Total | 6 | ||
Quantitative grading of causality: ≤0, excluded; 1–2, unlikely; 3–5, possible; 6–8 probable; ≥9, highly probable.