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Table 6 Gender-specific signaling results

From: Postmarketing adverse events associated with onasemnogene abeparvovec: a real-world pharmacovigilance study

Female high-risk signals

ROR (95% CI)

Log2 ROR

p

vomiting

1.32( 1.05; 1.66 )

0.40

< 0.02

thrombotic microangiopathy

2.38( 1.10; 5.16)

1.25

< 0.05

troponin T increased

4.94( 1.69; 14.40)

2.30

< 0.005

proteinuria

2.98( 1.19; 7.46 )

1.57

< 0.02

haematuria

5.37( 1.58; 18.30)

2.43

< 0.01

haemolytic anaemia

10.69( 1.39; 82.43 )

3.42

< 0.02

urinary tract infection

7.99( 1.01; 63.22 )

3.00

< 0.05

generalised oedema#

/

/

< 0.001

atypical haemolytic uraemic syndrome #

/

/

< 0.001

Male high-risk signals

ROR (95% CI)

Log2 ROR

p

hepatic enzyme increased

0.73( 0.55; 0.97 )

-0.46

< 0.05

increased bronchial secretion

0.29( 0.11; 0.73 )

-1.80

< 0.01

respiratory tract infection

0.39( 0.17; 0.89)

-1.38

< 0.05

pallor

0.29( 0.09; 0.90 )

-1.79

< 0.05

blood creatine phosphokinase MB increased

0.19( 0.04; 0.90 )

-2.37

< 0.05

  1. #AEs occurred in females but not in males