Table 1.
Case characteristics.
| ED Visits for ADEs | |||
|---|---|---|---|
| Women | Men | p-Value | |
| N = 35,010 (%) | N = 26,845 (%) | ||
| Patient Age, Years | |||
| ≤5 | 1510 (4.3) | 1701 (6.3) | <0.001 |
| 6–19 | 1607 (4.6) | 1194 (4.5) | |
| 20–64 | 15,238 (43.5) | 10,801 (40.2) | |
| 65–79 | 8456 (24.2) | 7610 (28.4) | |
| ≥80 | 7880 (22.5) | 5295 (19.7) | |
| Not Available | 319 (0.9) | 244 (0.9) | |
| Median (IQR), Years | 62.4 (39.6–78.9) | 63.8 (40.8–77.9) | 0.108 |
| Patients’ Ethnicity | |||
| Asian | 467 (1.3) | 425 (1.6) | 0.005 |
| Black or African American | 291 (0.8) | 259 (1.0) | |
| Caucasian | 30,729 (87.8) | 23,503 (87.6) | |
| Other | 102 (0.3) | 54 (0.2) | |
| Not available | 3421 (9.8) | 2604 (9.7) | |
| Type of Drug | |||
| Drug | 34,425 (98.3) | 26,259 (97.8) | <0.001 |
| Vaccine | 585 (1.7) | 586 (2.2) | |
| No. of Suspected Drugs Involved in the ADE | |||
| 1 | 14,948 (42.7) | 11,054 (41.2) | <0.001 |
| 2 | 5937 (17.0) | 4575 (17.0) | |
| 3–4 | 5988 (17.1) | 4409 (16.4) | |
| ≥5 | 8137 (23.2) | 6807 (25.4) | |
| Most Frequently Reported Suspected ATC Drug Classes | N = 44,119 | N = 34,242 | |
| Antithrombotic Agents (B01) | 7322 (16.6) | 8732 (15.5) | <0.001 |
| Antibacterials (J01) | 7203 (16.3) | 5186 (15.2) | <0.001 |
| Anti-inflammatory and Antirheumatic Products (M01) | 3805 (8.6) | 2812 (8.2) | 0.039 |
| Psycholeptics (N05) | 3717 (8.4) | 2052 (6.0) | <0.001 |
| Analgesics (N02) | 3559 (8.1) | 1915 (5.6) | <0.001 |
| Diabetes agents (A10) | 3051 (6.9) | 2991 (8.7) | <0.001 |
| Presence of a Suspected Drug with Parenteral Administration | |||
| No | 30,478 (87.1) | 23,187 (86.4) | 0.013 |
| Yes | 4532 (12.9) | 3658 (13.6) | |
| Concomitant Drugs | |||
| No | 18,221 (52.1) | 13,691 (51.0) | 0.010 |
| Yes | 16,789 (48.0) | 13,154 (49.0) | |
| No. of Concomitant Drugs * | |||
| 0 | 18,221 (52.1) | 13,691 (51.0) | <0.001 |
| 1 | 4100 (11.7) | 2977 (11.1) | |
| 2 | 2980 (8.5) | 2220 (8.3) | |
| 3–4 | 4414 (12.6) | 3343 (12.5) | |
| ≥5 | 5295 (15.1) | 4614 (17.2) | |
| Most Frequently Reported Concomitant ATC Drug Classes | N = 61,184 | N = 50,843 | |
| Renin–Angiotensin System Inhibitors (C09) | 5943 (9.7) | 5175 (10.2) | 0.009 |
| Drugs for Acid Related Disorders (A02) | 5063 (8.3) | 4090 (8.0) | 0.162 |
| Diuretics (C03) | 4899 (8.0) | 3987 (7.8) | 0.311 |
| Antithrombotic Agents (B01) | 4851 (7.9) | 4273 (8.4) | 0.004 |
| Beta Blocking Agents (C07) | 4521 (7.4) | 4040 (8.0) | <0.001 |
| Presence of Comorbidities | |||
| No | 22,261 (63.6) | 16,684 (62.2) | <0.001 |
| Yes | 12,749 (36.4) | 10,161 (37.9) | |
| No. of Comorbidities | |||
| 0 | 22,261 (63.6) | 16,684 (62.2) | <0.001 |
| 1 | 6111 (17.5) | 4641 (17.3) | |
| 2 | 2819 (8.1) | 2243 (8.4) | |
| ≥3 | 3819 (10.9) | 3277 (12.2) | |
| Most Frequently Reported Comorbidities | |||
| Hypertension | 3892 (14.2) | 3261 (14.3) | <0.001 |
| Diabetes | 1391 (5.0) | 1306 (5.7) | |
| Atrial Fibrillation | 1321 (4.8) | 1207 (5.3) | |
| Allergic Disease | 1060 (3.8) | 577 (2.4) | |
| Heart Disease | 1023 (3.7) | 1413 (6.1) | |
| Depression | 1020 (3.7) | 372 (1.6) | |
| Dyslipidaemia | 828 (3.0) | 776 (3.4) | |
| Renal Failure | 808 (2.9) | 943 (4.09) | |
| Presence of CAM | |||
| No | 34,558 (98.7) | 26,569 (99.0) | 0.003 |
| Yes | 452 (1.3) | 276 (1.0) | |
| Type of Event | |||
| Abuse/Misuse | 1024 (2.9) | 550 (2.1) | <0.001 |
| Interactions | 281 (0.8) | 258 (1.0) | 0.036 |
| Overdose | 240 (0.7) | 147 (0.6) | 0.031 |
| Therapeutic Errors | 433 (1.2) | 399 (1.5) | 0.008 |
| Hospitalization | |||
| No | 24,418 (69.8) | 18,519 (69.0) | 0.042 |
| Yes | 10,592 (30.3) | 8326 (31.0) | |
ADE: adverse drug event; ATC: anatomical therapeutic chemical; CAM: complementary and alternative medicines; ED: emergency department; IQR: interquartile range. * Number of concomitant drugs: “0” means that patient was not taking concomitant drugs, but only 1 or more suspected drugs; “1” means that patient was taking only 1 concomitant drug with at least 1 suspected drug; “2” or “≥3” means that patient was taking 2 or more than 3 concomitant drugs with at least 1 suspected drug.