Table 2 Frequencies of drug-AE pairs, reporting rate by gender, and its ratio of women to men, summarized at SOC level.

From: Gender differences in adverse event reports associated with antidiabetic drugs

SOC

Women

Men

Risk ratiob (95% CI)

Drug-AE pairs

Reporting ratea

Drug-AE pairs

Reporting ratea

Overall

11,269

62.65

9905

48.64

1.29 (1.25–1.32)

Foetal disorders

194

1.08

2

0.01

109.82 (27.27–442.25)

Reproductive disorders

134

0.75

34

0.17

4.46 (3.06–6.50)

Special senses other, disorders

14

0.08

6

0.03

2.64 (1.02–6.87)

Hearing and vestibular disorders

46

0.26

20

0.10

2.60 (1.54–4.40)

Neoplasms

126

0.70

85

0.42

1.68 (1.27–2.21)

Application site disorders

296

1.65

206

1.01

1.63 (1.36–1.94)

Gastro-intestinal system disorders

2132

11.85

1538

7.55

1.57 (1.47–1.68)

Psychiatric disorders

531

2.95

384

1.89

1.57 (1.37–1.79)

Heart rate and rhythm disorders

112

0.62

91

0.45

1.39 (1.06–1.84)

Skin and appendages disorders

596

3.31

488

2.40

1.38 (1.23–1.56)

Musculo-skeletal system disorders

389

2.16

319

1.57

1.36 (1.19–1.6)

Metabolic and nutritional disorders

2343

13.03

1945

9.55

1.36 (1.28–1.45)

Central and peripheral nervous system disorders

927

5.15

818

4.02

1.28 (1.17–1.41)

Vision disorders

156

0.87

149

0.73

1.19 (0.95–1.48)

Resistance mechanism disorders

113

0.63

108

0.53

1.18 (0.91–1.54)

White cell and RES* disorders

146

0.81

142

0.70

1.16 (0.92–1.47)

Urinary system disorders

446

2.48

452

2.22

1.12 (0.98–1.27)

Body as a whole—general disorders

1060

5.89

1123

5.51

1.07 (0.98–1.16)

Secondary terms—events

370

2.06

394

1.93

1.06 (0.92–1.23)

Vascular (extracardiac) disorders

101

0.56

123

0.60

0.93 (0.71–1.21)

Respiratory system disorders

550

3.06

670

3.29

0.99 (0.83–1.04)

Endocrine disorders

19

0.11

25

0.12

0.86 (0.47–1.56)

Red blood cell disorders

52

0.29

78

0.38

0.75 (0.53–1.07)

Platelet, bleeding and clotting disorders

66

0.37

107

0.53

0.70 (0.51–0.95)

Cardiovascular disorders, general

117

0.65

192

0.94

0.69 (0.55–0.87)

Myo-, endo-, pericardial and valve disorders

52

0.29

86

0.42

0.68 (0.49–0.97)

Liver and biliary system disorders

176

0.98

319

1.57

0.62 (0.52–0.75)

Neonatal and infancy disorders

2

0.01

0

0

–

Collagen disorders

1

0.00

1

0

–

Poison specific terms

2

0.01

0

0

–

  1. SOC system organ class, AE adverse event, CI confidence interval.
  2. aReporting rate per 10,000 people was calculated over the total number of diabetes patients (women = 1,798,633; men = 2,036,300).
  3. bRisk ratio = reporting rate of women/reporting rate of men.
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