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Table 2 The top 20 most frequently reproted SMQs of DPP-4is

From: Adverse event profiles of dipeptidyl peptidase-4 inhibitors: data mining of the public version of the FDA adverse event reporting system

SMQs Saxagliptin Sitagliptin Linagliptin Vildagliptin DPP-4is
   N ROR(95% CI) N ROR(95% CI) N ROR(95% CI) N ROR(95% CI) N ROR(95% CI)
Gastrointestinal nonspecific inflammation and dysfunctional conditions 114 4.27 (3.48,5.23)* 948 3.23 (3.00,3.48)* 86 2.53 (2.02,3.17)* 37 2.50 (1.78,3.52)* 1180 3.39 (3.17,3.63)*
Hypersensitivity 113 8.04 (6.55,9.87)* 732 4.91 (4.51,5.35)* 68 3.68 (2.86,4.73)* 22 2.66 (1.73,4.10)* 932 5.47 (5.05,5.91)*
Acute pancreatitis 79 11.27 (8.87,14.33)* 738 14.99 (13.54,16.58)* 42 4.62 (3.37,6.33)* 7 1.69 (0.80,3.58) 862 16.32 (14.76,18.04)*
Haemodynamic oedema, effusions and fluid overload 40 2.26 (1.64,3.11)* 329 1.64 (1.46,1.84)* 23 1.06 (0.70,1.61) 21 2.32 (1.49,3.61)* 411 1.68 (1.52,1.87)*
Malignancies 21 1.97 (1.27,3.05)* 346 3.22 (2.86,3.62)* 34 2.76 (1.95,3.90)* 9 1.64 (0.85,3.19) 405 3.12 (2.79,3.48)*
Noninfectious diarrhoea 44 4.28 (3.15,5.83)* 250 2.15 (1.88,2.46)* 28 2.22 (1.52,3.25)* 20 3.75 (2.38,5.91)* 341 2.48 (2.20,2.79)*
Angioedema 52 10.82 (8.10,14.46)* 254 5.21 (4.52,6.01)* 30 4.96 (3.43,7.19)* 3 1.09 (0.35,3.40) 337 6.20 (5.44,7.07)*
Embolic and thrombotic events 10 0.05 (0.03,0.09) 180 0.07 (0.06,0.09) 30 0.13 (0.09,0.19) 19 0.20 (0.12,0.31) 239 0.08 (0.07,0.09)
Hepatic disorders 15 3.53 (2.11,5.92)* 148 3.40 (2.85,4.07)* 8 1.56 (0.78,3.15) 10 4.63 (2.46,8.72)* 179 3.45 (2.92,4.08)*
Cardiac failure 11 0.11 (0.06,0.21) 122 0.10 (0.09,0.12) 23 0.20 (0.13,0.31) 12 0.25 (0.14,0.44) 167 0.11 (0.10,0.13)
Hypertension 15 1.21 (0.73,2.02) 118 0.81 (0.68,0.98) 6 0.40 (0.18,0.90) 27 4.57 (3.08,6.78)* 166 0.94 (0.80,1.10)
Chronic kidney disease 7 0.67 (0.32,1.41) 137 1.16 (0.98,1.39) 12 0.98 (0.55,1.74) 7 1.33 (0.63,2.82) 162 1.12 (0.95,1.31)
Arthritis 6 1.93 (0.86,4.34) 79 2.39 (1.88,3.03)* 10 2.76 (1.47,5.17)* 3 1.89 (0.60,5.90) 97 2.43 (1.96,3.03)*
Gastrointestinal perforation, ulceration, haemorrhage or obstruction 6 1.60 (0.71,3.59) 66 1.58 (1.23,2.04)* 11 2.52 (1.38,4.58)* 7 3.72 (1.75,7.89)* 90 1.79 (1.44,2.24)*
Dyslipidaemia 8 1.38 (0.68,2.78) 70 1.05 (0.82,1.34) 2 0.29 (0.07,1.15) 3 1.01 (0.32,3.15) 82 1.00 (0.79,1.25)
Severe cutaneous adverse reactions 6 4.84 (2.14,10.91)* 62 5.34 (4.01,7.13)* 8 5.51 (2.72,11.19)* 4 6.30 (2.33,17.01)* 80 6.12 (4.69,8.00)*
Depression and suicide/self-injury 9 1.74 (0.90,3.37) 60 1.00 (0.77,1.30) 6 0.97 (0.44,2.18) 5 1.89 (0.78,4.59) 80 1.09 (0.87,1.37)
Retinal disorders 4 1.29 (0.48,3.45) 34 0.95 (0.67,1.34) 7 1.92 (0.91,4.07) 3 1.90 (0.61,5.93) 46 1.05 (0.78,1.42)
Taste and smell disorders 0 37 2.82 (1.99,4.00)* 2 1.34 (0.33,5.40) 4 6.32 (2.34,17.08)* 43 2.70 (1.94,3.76)*
Anaphylactic reaction 11 7.23 (3.94,13.26)* 25 1.40 (0.93,2.11) 3 1.61 (0.51,5.02) 3 3.74 (1.20,11.73)* 39 2.01 (1.45,2.78)*
  1. Dpp-4is Dipeptidyl peptidase-4 inhibitors
  2. N The number of adverse events reports
  3. ROR The reporting odds ratio
  4. CI The confidence interval
  5. SMQs Standardized MedDRA queries
  6. *: signal detected, see “Methods” for the criteria of detection