Table 3.
Signal detection of propacetamol using disproportionality methods and empirical Bayesian geometric mean in WHO-UMC VigiBase from 1987 to 2020.
| Cases of propacetamol (N, %) | Non-cases of propacetamol (N, %) | rOR (95% CI) | IC (IC025‡) | Signal | ||
|---|---|---|---|---|---|---|
| rOR§ | IC¶ | |||||
| Anaphylactic reaction | ||||||
| Asia | 75 (4.1) | 15,268 (25.4) | 0.13 (0.10–0.16) | − 2.59 (− 2.97) | ||
| Europe | 44 (2.7) | 1285 (4.1) | 0.65 (0.48–0.88) | − 0.57 (− 1.07) | ||
| Stevens–Johnson syndrome | ||||||
| Asia | 19 (4.8) | 15,324 (24.9) | 0.15 (0.10–0.24) | − 2.35 (− 3.12) | ||
| Europe | 40 (6.8) | 1289 (3.9) | 1.78 (1.29–2.47) | 0.76 (0.23) | O | |
| Thrombosis | ||||||
| Asia | 0 (0.0) | 15,343 (24.8) | N/A | N/A | ||
| Europe | 39 (23.2) | 1290 (3.9) | 7.45 (5.19–10.71) | 2.45 (1.92) | O | O |
| Dermatitis · Eczema | ||||||
| Asia | 0 (0.0) | 15,343 (24.8) | N/A | N/A | ||
| Europe | 77 (39.7) | 1252 (3.8) | 16.73 (12.48–22.42) | 3.23 (2.85) | O | O |
| Injection site reaction | ||||||
| Asia | 1157 (63.9) | 14,186 (23.6) | 5.72 (5.19–6.31) | 1.37 (1.27) | O | O |
| Europe | 76 (6.3) | 1253 (3.9) | 1.65 (1.30–2.10) | 0.65 (0.27) | O | |
AE adverse events, rOR reporting odds ratio, CI confidential interval, WHO-UMC World Health Organisation-Uppsala Monitoring Centre, IC information component.
†‘O’ within the column ‘Signal’ denotes that it met the threshold for a signal.
‡IC025 is lowest bound of 95% CI for IC.
§Safety signal detection with rOR assessed as AEs where thresholds of rOR > 2.
¶Safety signal detection with IC assessed as AEs where IC025 > 0.