From: Safety profile of faricimab: a multi-source pharmacovigilance analysis using FAERS and JADER
Characteristics | FAERS | JADER | ||
---|---|---|---|---|
 | Number | Proportion (%) | Number | Proportion (%) |
Number of events | 4234 | 142 | ||
Gender | ||||
 Female | 1707 | 40.3 | 53 | 37.3 |
 Male | 1524 | 36 | 78 | 54.9 |
 Missing | 1003 | 23.7 | 11 | 7.7 |
Weight | ||||
 <50 kg | 17 | 0.4 | 4 | 2.8 |
 50–80 kg | 196 | 4.6 | 28 | 19.6 |
 >80 kg | 135 | 3.2 | 1 | 0.7 |
 Missing | 3886 | 91.8 | 109 | 76.8 |
Age | ||||
 <18 years | 93 | 2.2 | – | – |
 18–40 years | 70 | 1.7 | – | – |
 41–60 years | 483 | 11.4 | 11 | 7.7 |
 61–80 years | 1332 | 31.5 | 81 | 57 |
 ≥81 years | 563 | 13.3 | 40 | 28.2 |
 Missing | 1693 | 40 | 10 | 7 |
Occupation | ||||
 Medical doctor | 2478 | 58.5 | 137 | 96.5 |
 Consumer | 1401 | 33.1 | 1 | 0.7 |
 Health Professional | 271 | 6.4 | 1 | 0.7 |
 Pharmacist | 77 | 1.8 | 3 | 2.1 |
 Missing | 7 | 0.2 | 0 | 0 |
Report country | ||||
 United States | 2167 | 51.2 | – | – |
 India | 333 | 7.9 | – | – |
 Japan | 284 | 6.7 | 142 | 100 |
 Canada | 232 | 5.5 | – | – |
 France | 175 | 4.1 | – | – |
 United Kingdom | 173 | 4.1 | – | – |
 Australia | 140 | 3.3 | – | – |
 Korea, South | 121 | 2.9 | – | – |
 Germany | 90 | 2.1 | – | – |
 South Africa | 59 | 1.4 | – | – |
Outcome | ||||
 Hospitalization | 170 | 4 | – | – |
 Death | 129 | 3 | 5 | 3.5 |
 Disability | 52 | 1.2 | – | – |
 Life-threatening | 17 | 0.4 | – | – |
 Required Intervention | 5 | 0.1 | – | – |
Outcome | ||||
 Congenital anomaly | 2 | 0 | – | – |
 Partially Recovered | – | – | 40 | 28.2 |
 Recovered | – | – | 37 | 26.1 |
 Not Recovered | – | – | 35 | 24.6 |
 Sequelae Present | – | – | 6 | 4.2 |
 Other | 639 | 15.1 | – | – |
 Missing | 1014 | 23.9 | 19 | 13.4 |
Indications(top five) | ||||
 Neovascular age-related macular degeneration | 1354 | 32 | 83 | 58.5 |
 Product used for unknown indication | 879 | 20.8 | – | – |
 Diabetic retinal oedema | 603 | 14.2 | 39 | 27.5 |
 Age-related macular degeneration | 225 | 5.3 | 17 | 12 |
 Retinal vein occlusion | 202 | 4.8 | 1 | 0.7 |
 Polypoidal choroidal vasculopathy | – | – | 2 | 1.4 |