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Table 7 Age-specific signalling results

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

High-risk signals at ≤ 2 years of age

ROR (95% CI)

Log2ROR

p

lethargy

3.10( 1.23; 7.81)

1.63

<0.025

monocyte count increased

4.16( 1.39; 12.43 )

2.06

<0.02

blood creatinine decreased

4.88( 1.41; 16.96 )

2.29

<0.02

neutrophil count decreased

4.21( 1.19; 14.88 )

2.08

<0.05

High-risk signals at >2 years of age

ROR (95% CI)

Log2ROR

p

hypertension

0.43( 0.21; 0.88 )

-1.23

<0.05

haematuria

0.25( 0.08; 0.76 )

-2.00

<0.02

rhinovirus infection

0.43( 0.21; 0.88 )

-1.23

<0.05

blood creatine phosphokinase increased

0.20( 0.08; 0.53 )

-2.32

< 0.001

malaise

0.25( 0.08; 0.76 )

-2.00

<0.02

headache

0.12( 0.01; 0.95 )

-3.08

<0.05