Table 2.
Characteristics of “drug ineffective” and non-drug ineffective reports during the study period
| Characteristic | DI reports (N = 247,513) | Non-DI reports (N = 3,625,330) | ||
|---|---|---|---|---|
| N | % | N | % | |
| Report type | ||||
| Manufacturer | 241,291 | 97.5 | 3,482,423 | 96.1 |
| Direct | 6222 | 2.5 | 142,907 | 3.9 |
| Reporter type | ||||
| Consumer | 172,834 | 69.8 | 1,744,954 | 48.1 |
| Healthcare provider | 69,770 | 28.2 | 1,692,858 | 46.7 |
| Other | 444 | 0.2 | 115,558 | 3.2 |
| Missing | 4465 | 1.8 | 71,960 | 2 |
| Reporter country | ||||
| USA | 217,966 | 88 | 2,673,274 | 73.7 |
| Non-USA | 29,547 | 12 | 952,056 | 26.3 |
| Patient age (years) | ||||
| 0–17 | 6007 | 2.4 | 110,215 | 3 |
| 18–64 | 80,313 | 32.4 | 1,341,823 | 37 |
| ≥ 65 | 38,612 | 15.6 | 771,500 | 21.3 |
| Missing | 122,581 | 49.5 | 1,401,792 | 38.7 |
| Patient gender | ||||
| Female | 139,671 | 56.4 | 2,037,500 | 56.2 |
| Male | 82,326 | 33.3 | 1,261,002 | 34.8 |
| Unknown/null | 25,516 | 10.3 | 326,828 | 9 |
| All outcomes | ||||
| Hospitalization | 20,380 | 8.2 | 829,646 | 22.9 |
| Death | 4842 | 2 | 365,601 | 10.1 |
| Disability | 2832 | 1.1 | 67,991 | 1.9 |
| Life threatening | 2150 | 0.9 | 85,168 | 2.3 |
| Required intervention | 179 | < 0.1 | 10,919 | 0.3 |
| Congenital anomaly | 13 | < 0.1 | 14,408 | 0.4 |
| Other | 49,853 | 20.1 | 1,184,076 | 32.7 |
| No serious outcome was reported | 182,628 | 73.8 | 1,583,848 | 43.7 |
| Primary suspect product’s application type | ||||
| NDA | 144,168 | 58.3 | 1,973,700 | 54.4 |
| BLA | 48,946 | 19.8 | 822,300 | 22.7 |
| ANDA | 19,704 | 8 | 271,748 | 7.5 |
| Missing | 34,695 | 14 | 557,582 | 15.4 |
| Additional PTs other than DI | ||||
| Reported | 153,555 | 62 | ||
| Not reported | 93,958 | 38 | ||
ANDA abbreviated new drug application, BLA biologics license application, DI drug ineffective, FAERS FDA Adverse Event Reporting System, NDA new drug application, PT preferred term