TABLE 3.
Ten disproportionate reporting signals with the highest shrinkage observed‐to‐expected ratios.
| MedDRA preferred term for the adverse reaction | Kratom‐related report counts | Log OE ratios (95% CrI) | OE ratios (95% CrI) | ROR (95% CI) |
|---|---|---|---|---|
| Accidental death | 35 | 5.98 (5.41, 6.38) | 63.1 (42.5, 83.3) | 563.5 (402.7, 788.3) |
| Drug screen positive | 15 | 4.43 (3.56, 5.03) | 21.6 (11.8, 32.7) | 68.8 (41.4, 114.3) |
| Product complaint | 12 | 4.37 (3.39, 5.03) | 20.7 (10.5, 32.7) | 113.6 (64.4, 200.5) |
| Withdrawal syndrome | 26 | 4.2 (3.54, 4.66) | 18.4 (11.6, 25.3) | 28.0 (19.0, 41.2) |
| Toxicity to various agents | 87 | 4.02 (3.66, 4.27) | 16.2 (12.6, 19.3) | 18.6 (15.0, 23.1) |
| Drug dependence | 53 | 3.86 (3.41, 4.19) | 14.5 (10.6, 18.3) | 17.2 (13.1, 22.6) |
| Drug abuse | 33 | 3.78 (3.2, 4.19) | 13.7 (9.2, 18.3) | 17.4 (12.3, 24.5) |
| Drug withdrawal syndrome | 23 | 3.38 (2.68, 3.87) | 10.4 (6.4, 14.6) | 13.3 (8.8, 20.0) |
| Dependence | 7 | 3.35 (2.04, 4.2) | 10.2 (4.1, 18.4) | 29.5 (14.1, 62.0) |
| Drug withdrawal syndrome neonatal | 9 | 3.32 (2.18, 4.08) | 10.0 (4.5, 16.9) | 19.9 (10.3, 38.3) |
Abbreviations: CI, confidence intervals; CrI, credibility intervals; Log, logarithm; OE, observed‐to‐expected; ROR, reporting odds ratio.