pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Detected signals of varenicline fulfilling the criteria for signal by three data mining indices including PRR, ROR and IC
| No. | PRR | ROR | χ2 | IC | IC 95% LCI | AEs in drug label | ||
|---|---|---|---|---|---|---|---|---|
| MFDS |
FDA |
|||||||
| Nausea | 368 | 2.4 | 2.9 | 345.5 | 1.3 | 1.1 | Y | Y |
| Insomnia | 117 | 7.2 | 7.7 | 627.2 | 2.9 | 2.6 | Y | Y |
| Dyspepsia | 106 | 3.0 | 3.2 | 143.7 | 1.6 | 1.3 | Y | Y |
| Headache | 69 | 2.3 | 2.4 | 51.6 | 1.2 | 0.9 | Y | Y |
| Dreaming abnormal | 59 | 601.2 | 627.7 | 26877.8 | 8.9 | 8.4 | Y | Y |
| Depression | 23 | 13.9 | 14.1 | 272.5 | 3.8 | 3.2 | Y | Y |
| Malaise | 22 | 4.3 | 4.4 | 56.3 | 2.2 | 1.6 | Y | Y |
| Nightmares | 21 | 109.0 | 110.7 | 2126.7 | 6.8 | 6.1 | Y | Y |
| Sleep disorder | 21 | 22.1 | 22.4 | 418.4 | 4.5 | 3.9 | Y | Y |
| Hypotonia | 20 | 21.8 | 22.1 | 392.0 | 4.5 | 3.9 | N | N |
| Appetite increased | 11 | 11.4 | 11.5 | 103.5 | 3.6 | 2.8 | Y | Y |
| Weight increase | 10 | 3.4 | 3.4 | 17.1 | 1.9 | 1.0 | Y | Y |
| Anxiety | 8 | 2.3 | 2.3 | 6.0 | 1.4 | 0.4 | Y | Y |
| Amnesia | 6 | 10.0 | 10.1 | 48.6 | 3.5 | 2.4 | Y | Y |
| Incorrect dose administered | 5 | 20.3 | 20.3 | 90.7 | 4.6 | 3.4 | N | N |
| Mood swings | 4 | 23.3 | 23.4 | 84.4 | 4.8 | 3.5 | Y | Y |
| Aggressive reaction | 3 | 12.4 | 12.4 | 31.1 | 4.0 | 2.6 | Y | Y |
| Suicide attempt | 3 | 12.1 | 12.1 | 30.4 | 4.0 | 2.6 | Y | Y |
*PRR, Proportional Reporting Ratio; ROR, Reporting Odds Ratio; χ2, chi-squared; IC 95% LCI, Information Component lower limit of 95% confidence interval; AEs, Adverse Events; MFDS, Ministry of Food and Drug Safety; FDA, Food and Drug Administration.