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Table 3 Demographics and characteristics of population

From: Post-market safety profile of cefiderocol: a real-world pharmacovigilance exploratory analysis based on U.S. FDA adverse event reporting system (FAERS)

Factors

Number of events(%)

Gender

 

Female (%)

67(24.72)

Male (%)

96(35.42)

Not Specified (%)

108(39.85)

Age

 

<18(%)

1(0. 37)

18–44(%)

33(12.18)

45–64(%)

53(19.56)

≥65(%)

56(20.66)

Not Specified (%)

128(47.23)

Report year

 

2020(%)

17(6.27)

2021(%)

26(9.59)

2022(%)

70(25.83)

2023(%)

77(28.41)

2024Q1-Q3(%)

81(29.89)

Reporter

 

Consumer (%)

15(5.54)

Not Specified (%)

1(0.37)

Pharmacist (%)

139(51.29)

Physician (%)

116(42.80)

Reported countries

 

United States of America (%)

73(26.94)

Italy (%)

48(17.71)

France (%)

41(15.13)

Japan (%)

26(9.59)

Germany (%)

24(8.86)

Serious criteria

 

Serious reports of events

250(92.25)

Non-serous reports of events

21(7.75)

Serious outcome

 

Life-Threatening (%)

22(8.12)

Hospitalization - Initial or Prolonged (%)

44(16.24)

Disability (%)

4(1.48)

Death (%)

148(54.61)

Congenital Anomaly (%)

0(0.00)

Required Intervention to Prevent Permanent Impairment/Damage (%)

1(0.37)

Other (%)

79(29.15)

Adverse event occurrence time - medication date (days)

 

0–30(%)

100(36.90)

31–60(%)

5(1.85)

61–90(%)

1(0.37)

>90(%)

0(0.00)

Not Specified (%)

165(60.89)

Adverse event occurrence time - medication date (days)

 

N(missing)

 

Mean (SD)

10.80(12.41)

Median (Q1, Q3)

6.50(2.00,15.00)

Min, Max

0.00,82.00

Body weight (Kg)

 

N(Missing)

42(229)

Mean (SD)

77.88(27.27)

Median (Q1, Q3)

72.90(61.00,90.00)

Min, Max

32.40,170.00