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Table 1 Characteristics of hepatic adverse events in children in the period 2004–2020

From: Liver injury in children: signal analysis of suspected drugs based on the food and drug administration adverse event reporting system

Characteristics

Total reports, n (%)

Sex

 

 Male

7018 (49.6)

 Female

6385 (45.2)

 Missing or unknown

740 (5.2)

Age (years)

 

 0–2

2358 (16.7)

 3–5

2048 (14.5)

 6–18

9737 (68.8)

Country (top five)

 

 US

5073 (35.8)

 Japan

1029 (7.3)

 France

1013 (7.2)

 Great Britain

964 (6.8)

 Germany

531 (3.8)

Outcome

 

 Hospitalization

7207 (37.2)

 Death

1878 (9.7)

 Life-threatening

1535 (7.9)

 Disability

448 (2.3)

 Congenital anomaly

227 (1.2)

 Required intervention

162 (0.8)

 Generating injury

162 (0.8)

 Other serious or missing outcomes

7758 (40.0)