Table 3.
Clinical priority assessing results of disproportionality signals.
| PTs | n | ROR025 | Death (n) | IMEs/DMEs |
Relevant evidence evaluation |
Priority level (score) |
|---|---|---|---|---|---|---|
| Nausea | 2,369 | 7.20 | 0 | NA | ++ | Moderate (6) |
| Vomiting | 1,338 | 6.33 | 3 | NA | ++ | Moderate (6) |
| Diarrhea | 1,195 | 3.50 | 0 | NA | ++ | Moderate (5) |
| Constipation | 663 | 5.75 | 0 | NA | ++ | Moderate (6) |
| Abdominal pain upper | 490 | 4.53 | 2 | NA | ++ | Moderate (5) |
| Abdominal pain | 398 | 3.28 | 1 | NA | ++ | Moderate (5) |
| Pancreatitis | 389 | 18.29 | 2 | DME | ++ | Strong (8) |
| Abdominal discomfort | 340 | 3.24 | 0 | NA | ++ | Moderate (5) |
| Abdominal distension | 332 | 6.14 | 1 | NA | ++ | Moderate (6) |
| Eructation | 320 | 42.03 | 0 | NA | ++ | Moderate (6) |
| Flatulence | 272 | 9.28 | 0 | NA | ++ | Moderate (6) |
| Dyspepsia | 237 | 4.76 | 0 | NA | ++ | Moderate (5) |
| Gastrooesophageal reflux disease | 167 | 3.65 | 0 | NA | ++ | Moderate (5) |
| Gastrointestinal disorder | 154 | 3.03 | 1 | NA | ++ | Moderate (5) |
| Dysgeusia | 91 | 2.84 | 0 | IME | ++ | Moderate (6) |
| Taste disorder | 83 | 5.02 | 0 | IME | ++ | Moderate (7) |
| Dry moutha | 74 | 1.63 | 0 | NA | – | Weak (2) |
| Retching | 66 | 5.42 | 0 | NA | ++ | Moderate (6) |
| Hypophagiaa | 64 | 3.93 | 0 | NA | – | Weak (3) |
| Pancreatitis acute | 61 | 4.52 | 1 | DME | ++ | Moderate (7) |
| Pancreatic carcinomaa | 49 | 1.31 | 7 | NA | ++ | Weak (3) |
| Impaired gastric emptyinga | 48 | 8.88 | 0 | IME | + | Moderate (5) |
| Hiccups | 47 | 9.83 | 0 | NA | ++ | Moderate (5) |
| Gastric disorder | 42 | 1.26 | 0 | NA | ++ | Weak (3) |
| Ageusia | 41 | 2.45 | 0 | IME | + | Weak (4) |
| Gastritis | 37 | 2.21 | 0 | IME | ++ | Moderate (5) |
| Gastrointestinal sounds abnormala | 32 | 9.99 | 0 | NA | – | Weak (3) |
| Vomiting projectile | 24 | 13.29 | 0 | NA | + | Weak (4) |
| Gastroenteritis viral | 23 | 1.74 | 0 | IME | + | Weak (3) |
| Bowel movement irregularitya | 21 | 3.14 | 0 | NA | – | Weak (2) |
| Gastroenteritis | 20 | 1.77 | 0 | IME | + | Weak (3) |
| Gastrointestinal pain | 18 | 1.97 | 0 | NA | + | Weak (2) |
| Feces discoloreda | 17 | 1.03 | 0 | NA | – | Weak (1) |
| Obstructive pancreatitisa | 16 | 18.81 | 0 | IME | + | Moderate (5) |
| Paraesthesia orala | 14 | 1.20 | 0 | IME | – | Weak (2) |
| Abnormal fecesa | 14 | 1.85 | 0 | NA | – | Weak (1) |
| Pancreatic carcinoma metastatica | 12 | 5.62 | 3 | IME | – | Moderate (5) |
| Regurgitation | 12 | 5.03 | 0 | NA | + | Weak (4) |
| Hypoaesthesia orala | 12 | 1.01 | 0 | IME | – | Weak (2) |
| Appendicitisa | 12 | 1.46 | 0 | NA | – | Weak (1) |
| Epigastric discomfort | 11 | 2.78 | 0 | NA | + | Weak (3) |
| Oropharyngeal discomforta | 11 | 1.12 | 0 | NA | – | Weak (1) |
| Early satietya | 10 | 8.23 | 0 | NA | – | Weak (3) |
| Feces softa | 10 | 1.25 | 0 | NA | – | Weak (1) |
| Dry throata | 10 | 1.08 | 0 | NA | – | Weak (1) |
A priority score between 8 and 10, 5–7 or 0–4 represents the signal with strong, moderate or weak clinical priority, respectively.
NA, Not Applicable (for relevant criterias); n, number of cases; PTs, Preferred Terms; ROR025, the lower limit of 95% confidence interval of ROR.
a
Emerging finding of semaglutide-associated gastrointestinal AEs from FAERS database.