Table 1.
Baseline characteristics of all cases and non-cases adverse event reports for propacetamol and other parenteral antipyretics in WHO-UMC VigiBase from 1987 to 2020.
| Asia (N, %) | Europe (N, %) | |||||
|---|---|---|---|---|---|---|
| Cases† | Non-cases | p value | Cases | Non-cases | p value | |
| Number of reports | 2934 (8.8) | 30,370 (91.2) | 2407 (15.1) | 13,588 (85.0) | ||
| Age (years) | < 0.0001 | < 0.0001 | ||||
| 0–1 | 6 (0.2) | 171 (0.6) | 8 (0.3) | 376 (2.8) | ||
| 2–17 | 158 (5.4) | 1573 (5.2) | 107 (4.5) | 578 (4.3) | ||
| 18–44 | 1090 (37.2) | 12,540 (41.3) | 680 (28.3) | 3438 (25.3) | ||
| 45–64 | 1015 (34.6) | 9615 (31.7) | 804 (33.4) | 4072 (30.0) | ||
| ≥ 65 | 594 (20.3) | 5678 (18.7) | 615 (25.6) | 4320 (31.8) | ||
| Unknown | 71 (2.4) | 793 (2.6) | 193 (8.0) | 804 (5.9) | ||
| Sex | 0.8486 | < 0.0001 | ||||
| Male | 1238 (42.2) | 12,870 (42.4) | 941 (39.1) | 5937 (43.7) | ||
| Female | 1696 (57.8) | 17,500 (57.6) | 1466 (60.9) | 7651 (56.3) | ||
| Report type | < 0.0001 | < 0.0001 | ||||
| Spontaneous | 2823 (96.2) | 29,628 (97.6) | 2267 (94.2) | 12,314 (90.6) | ||
| Report from study‡ | 34 (1.2) | 169 (0.6) | 41 (1.7) | 749 (5.5) | ||
| Other | 15 (0.5) | 55 (0.2) | 99 (4.1) | 524 (3.9) | ||
| Unknown | 62 (2.1) | 518 (1.7) | 0 (0.0) | 1 (0.0) | ||
| Serious | < 0.0001 | < 0.0001 | ||||
| Yes | 551 (18.8) | 2762 (9.1) | < 0.0001 | 898 (37.3) | 5491 (40.4) | < 0.0001 |
| Death | 18 (3.3) | 53 (1.9) | 42 (4.7) | 368 (6.7) | ||
| Life threatening | 121 (22.0) | 440 (15.9) | 356 (39.6) | 868 (15.8) | ||
| Disabling/incapacitating | 1 (0.2) | 24 (0.9) | 6 (0.7) | 44 (0.8) | ||
| Caused/prolonged hospitalization | 233 (42.3) | 885 (32.0) | 324 (36.1) | 2746 (50.0) | ||
| Congenital anomaly/birth defect | 2 (0.4) | 6 (0.2) | 0 (0.0) | 0 (0.0) | ||
| Other | 176 (31.9) | 1274 (49.0) | 170 (18.9) | 1465 (26.7) | ||
| No | 1267 (43.2) | 19,428 (64.0) | 580 (24.1) | 3891 (28.6) | ||
| Unknown | 1116 (38.0) | 8180 (26.9) | 929 (38.6) | 4206 (31.0) | ||
| Report source by professions | < 0.0001 | < 0.0001 | ||||
| Physician | 1036 (35.3) | 9664 (31.8) | 1705 (70.8) | 10,355 (76.2) | ||
| Pharmacist | 176 (6.0) | 3355 (11.1) | 281 (11.7) | 1478 (10.9) | ||
| Other healthcare professional | 998 (34.0) | 11,715 (38.6) | 215 (8.9) | 808 (6.0) | ||
| Consumer/non-healthcare professional | 71 (2.4) | 1852 (6.1) | 44 (1.8) | 299 (2.2) | ||
| Lawyer | 1 (0.0) | 3 (0.0) | 0 (0.0) | 4 (0.0) | ||
| Unknown | 652 (22.2) | 3781 (12.5) | 162 (6.7) | 644 (4.7) | ||
AE adverse events, WHO-UMC World Health Organisation-Uppsala Monitoring Centre.
†Cases of propacetamol and other parenteral antipyretics that included injection site reaction, dermatitis, eczema, thrombosis, Stevens–Johnson syndrome, and anaphylactic reaction related to MedDRA preferred terms.
‡Report from study included any AE reports from the previous studies or literature.