Table 5 Mining results of the potential alert signals of onasemnogene abeparvovec

Investigations

aspartate aminotransferase increased (284)^#

69.75(61.45;79.18)

5.62(5.19)

alanine aminotransferase increased (260)^#

54.28(47.60;61.91)

5.31(4.87)

hepatic enzyme increased (237)^#

46.86(40.88;53.72)

5.13(4.67)

platelet count decreased (140)^#

15.89(13.37;18.88)

3.75(3.18)

liver function test increased (116)^#

73.73(61.05;89.03)

5.45(4.82)

troponin I increased (113)^#

895.21(734.43;1091.18)

6.65(5.98)

transaminases increased (87)^#

45.79(36.90;56.81)

4.89(4.16)

troponin increased (83)^#

143.49(114.96;179.10)

5.72(4.97)

blood lactate dehydrogenase increased (71)^*

49.18(38.78;62.39)

4.86(4.06 )

oxygen saturation decreased (60)^*

13.17(10.18;17.04)

3.44(2.58)

body temperature increased (39)^#

21.04(15.31;28.90)

3.82(2.76)

troponin T increased (33)^*

313.30(220.85;444.44)

4.98(3.81)

white blood cell count decreased (33)^*

3.46(2.45;4.88)

1.71(0.56)

blood creatine phosphokinase increased (30)^*

11.056(7.71;15.86)

3.09(1.89)

gamma-glutamyltransferase increased (30)^*

14.69(10.24;21.08)

3.38(2.17)

platelet count increased (30)^*

26.11(18.20;37.48)

3.88(2.68)

white blood cell count increased (29)^*

8.31(5.76;11.99)

2.77(1.55)

heart rate increased (28)^*

3.21(2.21;4.66)

1.61(0.37)

blood bilirubin increased (22)^*

8.95(5.87;13.62)

2.78(1.39)

monocyte count increased (22)^*

70.24(46.06;107.10)

4.18(2.79)

c-reactive protein increased (21)^*

6.76(4.40;10.40)

2.47(1.05)

blood creatinine decreased (19)^*

70.44(44.76;110.88)

4.04(2.54)

blood creatinine increased(16)^*

2.63(1.61;4.31)

1.26(0.55)

Respiratory, thoracic and mediastinal disorders

cough (86)^*

3.66(2.95;4.55)

1.8(1.07)

respiratory failure (44)^*

6.86(5.09;9.25)

2.61(1.60)

respiratory distress (37)^*

15.12(10.92;20.95)

3.48(2.39)

rhinorrhoea (36)^*

6.58(4.73;9.15)

2.53(1.43)

respiratory disorder (34)^*

12.99(9.25;18.24)

3.3(2.16)

atelectasis (33)^*

37.76(26.74;53.31)

4.21(3.06)

increased bronchial secretion (26)^*

142.71(96.63;210.77)

4.56(3.26)

aspiration (20)^*

21.71(13.97;33.75)

3.51(2.05)

hypoxia (20)^*

6.60(4.25;10.26)

2.44(0.98)

productive cough (19)^*

4.85(3.08;7.62)

2.08(0.59)

tachypnoea (19)^*

16.40(10.43;25.79)

3.27(1.78)

acute respiratory failure (18)^*

11.16(7.01;17.76)

2.93(1.39)

pneumothorax (18)^*

13.03(8.19;20.74)

3.06(1.53)

choking (15)^*

8.89(5.35;14.79)

2.65(0.98)

Infections and infestations

pneumonia (112)^*

4.18(3.46;5.06)

1.97(1.33)

rhinovirus infection (46)^*

175.80(130.86;236.17)

5.24(4.25)

covid-19 (44)^*

2.95(2.18;3.97)

1.51(0.50)

nasopharyngitis (40)^*

2.54(1.86;3.47)

1.31(0.26)

respiratory syncytial virus infection (40)^#

63.40(46.30;86.81)

4.67(3.62)

pneumonia aspiration (29)^*

13.42(9.30;19.38)

3.28(2.05)

respiratory tract infection (27)^*

12.58(8.60;18.40)

3.19(1.92)

upper respiratory tract infection (23)^*

5.74(3.80;8.66)

2.31(0.94)

viral infection (19)^*

6.77(4.31;10.64)

2.45(0.97)

lower respiratory tract infection (18)^*

4.93(3.10;7.85)

2.09(0.56)

bronchiolitis (15)^*

47.86(28.76;79.65)

3.69(2.02)

Gastrointestinal disorders

vomiting (434)^#

13.51(12.13;15.05

3.37(3.02)

dysphagia (52)^*

6.38(4.84;8.41)

2.53(1.60)

constipation (39)^*

2.14(1.56;2.95)

1.08(0.02)

salivary hypersecretion (22)^*

25.30(16.61;38.55)

3.67(2.28)

retching (17)^*

9.16(5.68;14.77)

2.72(1.15)

Blood and lymphatic system disorders

thrombocytopenia (170)^#

19.05(16.27;22.31)

3.99(3.46)

thrombotic microangiopathy (35)^#

45.00(32.18;62.92)

4.36(3.24)

leukopenia (27)^*

6.22(4.25;9.10)

2.43(1.16)

Hepatobiliary disorders

hepatic function abnormal (33)^#

10.53(7.46;14.85)

3.06(1.91)

hypertransaminasaemia (31)^#

68.23(47.78;97.42)

4.49(3.30)

General disorders and administration site conditions

pyrexia (461)^#

19.54(17.58;21.71)

3.85(3.51)

illness (24)^*

3.74(2.50;5.60)

1.8(0.46)

crying (17)^*

49.93(3.10;8.06)

2.1(0.53)

Metabolism and nutrition disorders

decreased appetite (95)^*

4.93(4.01;6.07)

2.2(1.51)

dehydration (35)^*

2.93(2.10;4.10)

1.5(0.38)

hyperkalaemia (16)^*

5.22(3.19;8.54)

2.14(0.52)

Cardiac disorders

tachycardia (50)^*

6.46(4.88;8.561)

2.54(1.60)

bradycardia (33)^*

6.84(4.85;9.66)

2.57(1.42)

cardiac arrest (23)^*

3.07(2.04;4.64)

1.55(0.18)

Vascular disorders

pallor (16)^*

6.45(3.94;10.56)

2.36(0.74)

cyanosis (15)^*

10.56(6.35;17.56)

2.8(1.14)

Renal and urinary disorders

proteinuria (28)^*

17.75(12.22;25.79)

3.53(2.28)

haematuria (21)^*

6.70(4.35;10.30)

2.46(1.04)

renal impairment(17)^#

2.28(1.42;3.68)

1.08(0.40)

Psychiatric disorders

irritability (53)^*

9.77(7.44;12.85)

3.06(2.15)

eating disorder (15)^*

7.77(4.68;12.92)

2.53(0.86)

Nervous system disorders

lethargy (29)^*

5.61(3.89;8.10)

2.31(1.09)

Musculoskeletal and connective tissue disorders

scoliosis (30)^*

53.84(37.50;77.31)

4.35(3.14)

muscular weakness (28)^*

2.78(1.92;4.04)

1.43(0.18)