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Table 3 Signal strength for DPP-4is at the PT level in FAERS

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

  PTs 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 Diarrhoea 42 4.17 (3.04,5.71)* 245 2.15 (1.88,2.46)* 23 1.85 (1.22,2.81)* 20 3.84 (2.44,6.04)* 329 2.44 (2.16,2.75)*
  Nausea 40 3.70 (2.68,5.11)* 327 2.82 (2.50,3.18)* 35 2.69 (1.91,3.79)* 14 2.47 (1.44,4.22)* 413 3.00 (2.69,3.34)*
  Vomiting 15 2.02 (1.21,3.38)* 160 1.97 (1.67,2.32)* 12 1.36 (0.77,2.40) 14 3.77 (2.20,6.46)* 200 2.04 (1.75,2.37)*
  Dyspepsia 10 5.54 (2.94,10.44)* 50 2.55 (1.89,3.44)* 7 3.24 (1.53,6.87)* 1 1.05 (0.15,7.49) 68 2.95 (2.27,3.85)*
Pancreas Acute pancreatitis 26 11.80 (7.89,17.65)* 119 5.50 (4.46,6.78)* 8 2.87 (1.42,5.80)* 6 5.01 (2.22,11.29)* 159 6.66 (5.50,8.07)*
Malignancies Pancreatic carcinoma 1 0.92 (0.13,6.58) 122 22.04 (16.77,28.97)* 4 3.18 (1.18,8.57)* 1 1.81 (0.25,12.97) 127 19.44 (14.76,25.60)*
Infection Nasopharyngitis 8 5.97 (2.94,12.12)* 34 2.30 (1.61,3.30)* 4 2.48 (0.92,6.66) 1 1.42 (0.20,10.12) 47 2.70 (1.97,3.71)*
  Pneumonia 6 1.47 (0.65,3.29) 85 1.90 (1.52,2.39)* 11 2.30 (1.26,4.19)* 10 4.92 (2.62,9.27)* 112 2.09 (1.71,2.56)*
  Upper respiratory tract infection 6 8.52 (3.75,19.36)* 71 15.71 (11.32,21.80)* 1 1.15 (0.16,8.25) 0 78 15.30 (11.01,21.24)*
  Urinary tract infection 5 1.79 (0.74,4.33) 62 2.04 (1.57,2.66)* 7 2.13 (1.01,4.51)* 6 4.27 (1.90,9.61)* 79 2.16 (1.70,2.75)*
Musculoskeletal Arthralgia 13 3.46 (1.99,6.02)* 145 3.87 (3.22,4.64)* 10 2.23 (1.19,4.18)* 7 3.63 (1.71,7.71)* 173 3.88 (3.27,4.60)*
  Pain in extremity 10 1.96 (1.05,3.68)* 113 2.04 (1.67,2.48)* 10 1.66 (0.89,3.11) 6 2.31 (1.03,5.20)* 138 2.05 (1.72,2.46)*
  Myalgia 9 3.00 (1.55,5.82)* 133 4.64 (3.82,5.64)* 15 4.30 (2.56,7.21)* 3 1.93 (0.62,6.04) 159 4.71 (3.93,5.66)*
  Fracture 0 9 1.22 (0.62,2.41) 0 1 3.04 (0.42,21.80) 10 1.10 (0.58,2.09)
Cardiac Cardiac failure 5 1.00 (0.42,2.43) 43 0.74 (0.54,1.00) 9 1.54 (0.80,2.99) 5 1.99 (0.82,4.82) 61 0.86 (0.66,1.11)
  Cardiac failure congestive 5 0.06 (0.02,0.14) 53 0.05 (0.04,0.06) 6 0.06 (0.03,0.13) 1 0.02 (0,0.16) 65 0.05 (0.04,0.06)
  Myocardial infarction 3 0.02 (0.01,0.06) 122 0.06 (0.05,0.08) 14 0.08 (0.04,0.13) 10 0.13 (0.07,0.24) 149 0.06 (0.05,0.07)
Hypersensitivity and skin Angioedema 20 27.80 (17.30,44.65)* 50 7.06 (5.06,9.86)* 5 5.21 (2.13,12.72)* 0 75 10.90 (8.01,14.83)*
  Oedema peripheral 19 3.95 (2.49,6.26)* 124 2.36 (1.95,2.85)* 1 0.17 (0.02,1.20) 13 5.32 (3.05,9.30)* 156 2.47 (2.08,2.94)*
  Pruritus 13 3.94 (2.26,6.86)* 138 4.26 (3.53,5.14)* 17 4.40 (2.70,7.16)* 4 2.33 (0.87,6.26) 171 4.52 (3.79,5.38)*
  Rash 38 9.76 (6.99,13.64)* 240 6.63 (5.70,7.72)* 10 2.01 (1.07,3.76)* 6 2.80 (1.24,6.29)* 294 7.17 (6.21,8.28)*
  Rash generalised 3 4.43 (1.41,13.96)* 42 7.27 (5.04,10.47)* 7 9.08 (4.23,19.49)* 0 52 8.09 (5.71,11.44)*
  Urticaria 21 12.47 (7.97,19.51)* 74 4.20 (3.25,5.43)* 10 4.78 (2.54,6.90)* 0 104 5.31 (4.22,6.67)*
  Pemphigoid 3 8.37 (2.63,26.64)* 9 2.25 (1.12,4.53)* 20 63.72 (37.92,107.09)* 16 112.37 (63.87,197.70)* 47 23.33 (14.44,37.68)*
General disorders Asthenia 8 1.36 (0.67,2.73) 111 1.71 (1.40,2.08)* 26 3.87 (2.61,5.75)* 4 1.33 (0.49,3.56) 148 1.89 (1.59,2.25)*
  Dizziness 15 1.75 (1.05,2.93)* 224 2.48 (2.15,2.86)* 25 2.51 (1.68,3.75)* 5 1.13 (0.47,2.74) 269 2.46 (2.16,2.81)*
  Fatigue 14 1.92 (1.13,3.27)* 141 1.74 (1.46,2.08)* 15 1.74 (1.04,2.91)* 5 1.33 (0.55,3.22) 175 1.78 (1.52,2.09)*
  Headache 19 2.87 (1.81,4.54)* 286 4.51 (3.95,5.15)* 22 2.82 (1.84,4.32)* 2 0.57 (0.14,2.30) 329 4.33 (3.82,4.91)*
  Malaise 14 2.26 (1.33,3.86)* 130 1.91 (1.59,2.29)* 13 1.77 (1.02,3.07)* 23 7.73 (5.04,11.84)* 180 2.22 (1.90,2.61)*
  Pain 18 2.18 (1.36,3.49)* 122 1.29 (1.07,1.55)* 13 1.32 (0.76,2.28) 1 0.23 (0.03,1.64) 154 1.33 (1.13,1.57)*
  1. FAERS FDA Adverse Event Reporting System
  2. Dpp-4is Dipeptidyl peptidase-4 inhibitors
  3. N The number of adverse events reports
  4. ROR The reporting odds ratio
  5. CI The confidence interval
  6. PTs Preferred Terms
  7. *: signal detected, see “Methods” for the criteria of detection