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. 2020 Dec 31;15(12):e0244239. doi: 10.1371/journal.pone.0244239

Table 4. The incidence of adverse drug reactions caused by prophylactic INH.

Number of cases a Incidence rate (95% CI) b
Mild-to-moderate adverse drug reactions 85 110.4 (88.2 to 136.5)
    AST/ALT elevation 31 40.3 (27.4 to 57.2)
    Peripheral neuropathy 26 33.8 (22.1 to 49.5)
    GI discomfort 10 13.0 (6.2 to 23.9)
    Skin rash 6 7.8 (2.9 to 17.0)
    Thrombocytopenia 5 6.5 (2.1 to 15.2)
    Anemia 1 1.3 (0.03 to 7.2)
    Leukopenia 1 1.3 (0.03 to 7.2)
    Anorexia 2 2.6 (0.3 to 9.4)
    Others c 3 3.9 (0.8 to 11.4)
Severe adverse drug reactions d 1 1.3 (0.03 to 7.2)
    Fulminant hepatitis 1 1.3 (0.03 to 7.2)

ALT, alanine aminotransferase; AST, aspartate aminotransferase; CI, confidence interval; GI, gastrointestinal; INH, isoniazid; NA, not applicable.

a The total observation period was 77.0 person-years for 152 episodes.

b Rate per 100 person-years.

c Including eosinophilia (n = 1), pruritus (n = 1), and general weakness (n = 1).

d Occurred in the high-risk subgroup.