Table 2.
Frequencies of drug-AE pairs, reporting rate by gender, and its ratio of women to men, summarized at SOC level.
| 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 | – |
SOC system organ class, AE adverse event, CI confidence interval.
aReporting rate per 10,000 people was calculated over the total number of diabetes patients (women = 1,798,633; men = 2,036,300).
bRisk ratio = reporting rate of women/reporting rate of men.