Table 2

Results of the disproportionality analysis

2004q1–2018q32013q1–2018q3
No indication filter SGLT2i All others SGLT2i All others
Reports, n45 92711 479 34945 8356 958 420
FG cases, n912862911388
FG/1000 (95% CI)2.0 (1.6 to 2.4)0.2 (0.2 to 0.3)2.0 (1.6 to 2.4)0.2 (0.2 to 0.2)
PRR (95% CI)7.95 (6.45 to 9.79)9.95 (8.05 to 12.30)
Diabetes indication SGLT2i All others SGLT2i All others
Reports, n29 808501 93229 716312 443
FG cases, n651326581
FG/1000 (95% CI)2.2 (1.7 to 2.7)0.3 (0.2 to 0.3)2.2 (1.7 to 2.7)0.3 (0.2 to 0.3)
PRR (95% CI)8.29 (6.16 to 11.16)8.44 (6.09 to 11.69)
No indication filter SGLT2i Other ATC10 class+ insulin SGLT2i Other ATC10 class+ insulin
Reports, n45 927945 91845 835555 472
FG cases, n9126891134
FG/1000 (95% CI)2.0 (1.6 to 2.4)0.3 (0.2 to 0.3)2.0 (1.6 to 2.4)0.2 (0.2 to 0.3)
PRR (95% CI)6.99 (5.51 to 8.87)8.23 (6.31 to 10.74)
Strict FG definition SGLT2i Other ATC10 class+ insulin SGLT2i Other ATC10 class+insulin + diabetes indication
Reports, n45 927945 91829 716306 824
FG cases, n622474674
FG/1000 (95% CI)1.3 (1.0 to 1.7)0.3 (0.2 to 0.3)1.5 (1.1 to 2.0)0.2 (0.2 to 0.3)
PRR (95% CI)5.17 (3.91 to 6.83)6.42 (4.44 to 9.27)
FG preferred term SGLT2i All others SGLT2i Other ATC10 class+insulin+diabetes indication
Reports, n45 927945 91829 716306 824
FG cases, n622474674
FG/1000 (95% CI)1.3 (1.0 to 1.7)0.3 (0.2 to 0.3)1.5 (1.1 to 2.0)0.2 (0.2 to 0.3)
PRR (95% CI)5.17 (3.91 to 6.83)6.42 (4.44 to 9.27)
  • For each analysis, the table reports the number of total adverse event (AE) reports, the number of reports listing Fournier’s gangrene (FG) as an AE, the rate with 95% CI of FG and the proportional reporting ratio (PRR) with 95% CI.