Table 4.

Screening criteria of adverse events associated with antimicrobials.

Type of Adverse Events	Criteria of Adverse Events
Allergic reaction	Allergic reactions reported spontaneously during the study period
Hematologic toxicity	Neutropenia: ANC < 1500, Thrombocytopenia: Platelet < 100 × 103/㎕ Exclusion criteria Patients on anti-neoplastic therapy Neutropenia: baseline ANC < 1500 or WBC < 3000 cells/㎕ Thrombocytopenia: baseline platelet < 100 × 103/㎕
Nephrotoxicity	Serum creatinine increased by 0.3 mg/dL or more after starting antimicrobials or by 1.5 times or more after starting antimicrobials Exclusion criteria Estimated glomerular filtration rate < 15 mL/min or dialysis
Hepatotoxicity	Baseline is within the normal range (1) ALT > upper limit of normal range (ULN) × 5 or (2) ALP > ULN × 2 (3) TB > ULN × 2 & ALT > ULN × 3 If baseline ALT is elevated (1) ALT > baseline ALT × 3 (2) ALP > baseline ALP × 2 LFT is more than 2 times higher than the upper limit of normal range, and when stopping antimicrobials at the physician’s judgment Exclusion criteria ALT elevation begins after antimicrobials are stopped Biliary tract stent treatment and liver transplantation within 3 days Diagnosed with viral hepatitis with abnormal laboratory test Baseline ALT is more than 5 times higher than the upper limit of the normal range
Antimicrobial associated diarrhea	Use of antidiarrhea drug (smectite, loperamide) and C. difficile toxin test negative or no test
C. difficile infection (CDI)	Occurs within 90 days of starting antimicrobials Positive result of C. difficile toxin test (ELISA or stool toxin) Oral metronidazole or oral vancomycin administration
	Exclusion criteria C. difficile toxin positive 60 days after the end of antimicrobials

ANC, absolute neutrophil count; WBC, white blood cell; ALT, alanine aminotransferase; ALP, alkaline phosphatase; TB, total bilirubin; LFT, liver function test.