Table 5.
Criteria for evaluating the severity of toxicity according to the type of adverse events.
| Type of Adverse Events | Severity | Definition |
|---|---|---|
| Hematologic Toxicity | ||
| Neutropenia | mild | ANC 1000–1500 |
| moderate | ANC 500–999 | |
| severe | ANC < 500 | |
| Thrombocytopenia | mild | Platelet 50–100 × 103/㎕ |
| moderate | Platelet 30–50 × 103/㎕ | |
| severe | Platelet < 30 × 103/㎕ | |
| Nephrotoxicity | mild | Less than twice the baseline |
| moderate | 2–3 times increase of baseline | |
| severe | More than 3 times the baseline | |
| Hepatotoxicity | mild | ALT ≤ upper limit of normal range (ULN) × 3 or baseline ALT × 1.5–3 |
| ALP ≤ ULN × 2.5 or baseline ALP × 2.0–2.5 | ||
| TB ≤ ULN × 1.5 or baseline TB × 1.0–1.5 | ||
| moderate | ALT ≤ ULN × 3.0–5.0 or baseline ALT × 3–5 | |
| ALP ≤ ULN × 2.5–5.0 or baseline ALP × 2.5–5.0 | ||
| TB ≤ ULN × 1.5–3.0 or baseline TB × 1.5–3.0 | ||
| severe | ALT > ULN × 5.0 or baseline ALT × 5.0 | |
| ALP > ULN × 5.0 or baseline ALP × 5.0 | ||
| TB > ULN × 3.0 or baseline TB × 3.0 | ||
| Diarrhea | ||
| Antimicrobial associated diarrhea | mild | Duration of treatment: less than 4 days |
| moderate | Duration of treatment: 4 ~ 7 days | |
| severe | Duration of treatment: more than 7 days | |
| C. difficile infection (CDI) a | mild | Treatment for less than 10 days with metronidazole alone |
| moderate | Vancomycin oral treatment for less than 10 days or vancomycin oral treatment for less than 10 days after metronidazole treatment is started. | |
| severe | Vancomycin oral combined with metronidazole injection treatment or vancomycin enema |
ANC, absolute neutrophil count; ALT, alanine aminotransferase; ALP, alkaline phosphatase; TB, total bilirubin. a The severity criteria of CDI was based on the 2010 version due to study period (2017).