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Table 1 Characteristics of ADR reports according to age group

From: Characteristics of pediatric adverse drug reaction reports in the Japanese Adverse Drug Event Report Database

 

Age group

 

< 10 years

n = 11,786 (55.2%)

10–19 years

n = 9573 (44.8%)

Sex

 Boy, n (%)

6305 (53.5)

4910 (51.3)

 Girl, n (%)

4777 (40.5)

4449 (46.5)

 Unexplained, n (%)

704 (6.0)

214 (2.2)

Report source

 Company, n (%)

11,652 (98.9)

9430 (98.5)

 Healthcare facility, n (%)

134 (1.1)

143 (1.5)

Reporter

 Doctor, n (%)

10,002 (78.4)

7901 (74.8)

 Pharmacist, n (%)

1218 (9.5)

1208 (11.4)

 Healthcare professional, n (%)

430 (3.4)

480 (4.5)

 Consumer, n (%)

449 (3.5)

501 (4.7)

 Lawyer, n (%)

2 (0.0)

0 (0.0)

 Unexplained, n (%)

656 (5.1)

472 (4.5)

 Total, n (%)

12,757 (100)

10,562 (100)

Number of suspected drugs per ADR report

 1, n (%)

8248 (70.0)

6679 (69.8)

 2, n (%)

1824 (15.5)

1449 (15.1)

 3, n (%)

798 (6.7)

634 (6.6)

 4, n (%)

394 (3.3)

322 (3.4)

 5, n (%)

234 (2.0)

165 (1.7)

 6, n (%)

100 (0.8)

131 (1.4)

 7, n (%)

71 (0.6)

68 (0.7)

 8, n (%)

52 (0.4)

33 (0.3)

 9, n (%)

24 (0.2)

31 (0.3)

  ≥ 10, n (%)

41 (0.3)

61 (0.6)

Number of suspected drugs per fatal ADR report (n)

 1, n (%)

328 (4.0)

215 (3.2)

 2, n (%)

93 (5.1)

61 (4.2)

 3, n (%)

57 (7.1)

38 (6.0)

 4, n (%)

28 (7.1)

16 (5.0)

  ≥ 5, n (%)

46 (8.8)

39 (8.0)

 Total, n (%)

552 (4.7)

369 (3.9)

  1. Abbreviation: ADR: adverse drug reaction