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Table 3 OR of reporting AEs by medication class of pregnancy in JADER, categorized based on system organ class (SOC)

From: Adverse event reports in patients taking psychiatric medication during pregnancy from spontaneous reports in Japan and the United States: an approach using latent class analysis

 

Class 1

n=338

Class 2

n=55

Class 3

n=285

Class 4

n=582

Class 5

n=63

Class 6

n=226

Class 7

n=25

Class 8

n=40

Class 9

n=6

Class 10

n=4

Class 11

n=30

Reports in pregnancy without psychiatric medications, n=5,876

SOC

# reports

OR (95%CI)

# reports

OR (95%CI)

# reports

OR (95%CI)

# reports

OR (95%CI)

# reports

OR (95%CI)

# reports

OR (95%CI)

# reports

OR (95%CI)

# reports

OR (95%CI)

# reports

OR (95%CI)

# reports

OR (95%CI)

# reports

OR (95%CI)

n (reference)

Preg

93

20

98

126

16

73

5

30

1

2

20

2,156

0.7 (0.5,0.8)

1.0 (0.6,1.7)

0.9 (0.7,1.2)

0.5 (0.4,0.6)

0.6 (0.3,1.0)

0.8 (0.6,1.1)

-

5.2 (2.5,10.6)

-

-

3.4 (1.6,7.4)

1.0

Cong

135

3

42

124

14

93

7

5

0

1

3

1,037

3.1 (2.5,3.9)

-

0.8 (0.6,1.1)

1.3 (1.0,1.6)

1.3 (0.7,2.4)

3.3 (2.5,4.3)

1.8 (0.8,4.4)

-

-

-

-

1.0

Resp

39

11

93

144

19

17

4

4

2

1

6

712

0.9 (0.7,1.3)

1.8 (0.9,3.5)

3.5 (2.7,4.6)

2.4 (1.9,2.9)

3.1 (1.8,5.4)

0.6 (0.4,1.0)

-

-

-

-

1.8 (0.7,4.5)

1.0

Genrl

37

7

65

169

15

21

5

1

2

1

1

252

2.7 (1.9,3.9)

3.3 (1.5,7.3)

6.6 (4.9,8.9)

9.1 (7.3,11.4)

7.0 (3.9,12.6)

2.3 (1.4,3.6)

-

-

-

-

-

1.0

Nerv

30

4

37

108

12

23

3

1

4

0

2

420

1.3 (0.9,1.9)

-

1.9 (1.4,2.8)

3.0 (2.3,3.7)

3.1 (1.6,5.8)

1.5 (0.9,2.3)

-

-

-

-

-

1.0

Psych

9

3

13

39

7

16

0

3

1

0

2

28

5.7 (2.7,12.2)

-

10.0 (5.1,19.5)

15.0 (9.2,24.6)

26.1 (10.9,62.3)

15.9 (8.5,29.9)

-

-

-

-

-

1.0

Inv

12

6

23

32

2

4

2

2

0

0

0

389

0.5 (0.3,0.9)

1.7 (0.7,4.1)

1.2 (0.8,1.9)

0.8 (0.6,1.2)

-

-

-

-

-

-

-

1.0

Metab

4

3

10

37

1

8

4

3

1

1

2

316

-

-

0.6 (0.3,1.2)

1.2 (0.8,1.7)

-

0.6 (0.3,1.3)

-

-

-

-

-

1.0

Inj&P

8

4

13

31

0

7

0

0

2

0

0

295

0.5 (0.2,0.9)

-

0.9 (0.5,1.6)

1.1 (0.7,1.6)

-

0.6 (0.3,1.3)

-

-

-

-

-

1.0

Card

11

2

2

29

2

6

2

1

0

0

1

429

0.4 (0.2,0.8)

-

-

0.7 (0.5,1.0)

-

0.3 (0.2,0.8)

-

-

-

-

-

1.0

Musc

9

2

18

17

2

5

2

0

0

0

0

153

1.0 (0.5,2.0)

-

2.5 (1.5,4.2)

1.1 (0.7,1.9)

-

-

-

-

-

-

-

1.0

Gastr

4

2

6

22

4

9

1

1

0

0

0

284

-

-

0.4 (0.2,1.0)

0.8 (0.5,1.2)

-

0.8 (0.4,1.6)

-

-

-

-

-

1.0

Surg

15

2

6

5

1

14

1

1

0

0

3

149

1.8 (1.0,3.1)

-

0.8 (0.4,1.9)

-

-

2.5 (1.4,4.5)

-

-

-

-

-

1.0

Blood

0

7

3

26

0

5

1

0

0

0

0

339

-

2.4 (1.1,5.3)

-

0.8 (0.5,1.1)

-

-

-

-

-

-

-

1.0

Skin

2

7

1

18

1

4

2

0

0

0

0

212

-

3.9 (1.7,8.7)

-

0.9 (0.5,1.4)

-

-

-

-

-

-

-

1.0

Hepat

3

6

3

17

0

3

0

1

0

0

0

184

-

3.8 (1.6,9.0)

-

0.9 (0.6,1.5)

-

-

-

-

-

-

-

1.0

Infec

0

2

3

12

1

5

3

0

0

0

1

194

-

-

-

0.6 (0.3,1.1)

-

-

-

-

-

-

-

1.0

Immun

1

3

0

14

0

0

1

0

0

0

0

172

-

-

-

0.8 (0.5,1.4)

-

-

-

-

-

-

-

1.0

Eye

2

0

3

6

1

4

0

0

0

0

0

43

-

-

-

1.4 (0.6,3.3)

-

-

-

-

-

-

-

1.0

Repro

2

0

2

9

1

1

0

1

0

0

0

160

-

-

-

0.6 (0.3,1.1)

-

-

-

-

-

-

-

1.0

Vasc

2

1

3

11

0

1

0

0

0

0

0

177

-

-

-

0.6 (0.3,1.1)

-

-

-

-

-

-

-

1.0

Neopl

1

1

0

3

1

4

0

0

0

0

0

46

-

-

-

-

-

-

-

-

-

-

-

1.0

Endo

1

0

3

3

0

1

0

0

1

0

0

56

-

-

-

-

-

-

-

-

-

-

-

1.0

Ear

3

0

0

2

1

2

0

0

0

0

0

16

-

-

-

-

-

-

-

-

-

-

-

1.0

Renal

1

1

1

3

0

1

0

0

0

0

0

167

-

-

-

-

-

-

-

-

-

-

-

1.0

SocCi

1

0

0

0

0

0

0

0

0

0

0

1

-

-

-

-

-

-

-

-

-

-

-

1.0

Prod

0

0

0

0

0

0

0

0

0

0

0

5

-

-

-

-

-

-

-

-

-

-

-

1.0

  1. Significant results with p<0.05 in boldface
  2. OR was estimated in cells with > 5 events
  3. AE Adverse event, OR Odds ratio, SOC System organ class, Blood Blood and lymphatic system disorders, Card Cardiac disorders, Cong Congenital, familial and genetic disorders, Ear Ear and labyrinth disorders, Endo Endocrine disorders, Eye Eye disorders, Gastr Gastrointestinal disorders, Genrl General disorders and administration site conditions, Hepat Hepatobiliary disorders, Immun Immune system disorders, Infec Infections and infestations, Inj&P Injury, poisoning and procedural complications, Inv Investigations, Metab Metabolism and nutrition disorders, Musc Musculoskeletal and connective tissue disorders, Neopl Neoplasms benign, malignant and unspecified (incl cysts and polyps), Nerv Nervous system disorders, Preg Pregnancy, puerperium and perinatal conditions, Prod Product issues, Psych Psychiatric disorders, Renal Renal and urinary disorders, Repro Reproductive system and breast disorders, Resp Respiratory, thoracic and mediastinal disorders, Skin Skin and subcutaneous tissue disorders, SocCi Social circumstances, Surg Surgical and medical procedures, Vasc Vascular disorders
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BMC Psychiatry

ISSN: 1471-244X

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