Table 2.
EUDRAVIGILANCE | FAERS | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Age | Sex | Subtotal | % | Total | % | Age | Sex | Subtotal | % | Total | % | ||
Tisagenlecleucel | 2 months - 2 years | F | 5 | 1.76 | 11 | 3.87 | Tisagenlecleucel | 2 months - 2 years | F | 4 | 1.01 | 12 | 3.02 |
M | 5 | 1.76 | M | 5 | 1.26 | ||||||||
NA | 1 | 0.35 | NA | 3 | 0.75 | ||||||||
3-11 Years | F | 19 | 6.69 | 53 | 18.66 | 3-11 years | F | 26 | 6.53 | 78 | 19.60 | ||
M | 31 | 10.92 | M | 48 | 12.06 | ||||||||
NA | 3 | 1.06 | NA | 4 | 1.01 | ||||||||
12-17 Years | F | 23 | 8.10 | 55 | 19.37 | 12-17 Years | F | 25 | 6.28 | 60 | 15.08 | ||
M | 28 | 9.86 | M | 30 | 7.54 | ||||||||
NA | 4 | 1.41 | NA | 5 | 1.26 | ||||||||
18-64 Years | F | 39 | 13.73 | 93 | 32.75 | 18-64 Years | F | 36 | 9.05 | 91 | 22.86 | ||
M | 47 | 16.55 | M | 51 | 12.81 | ||||||||
NA | 7 | 2.46 | NA | 4 | 1.01 | ||||||||
65-85 Years | F | 4 | 1.41 | 19 | 6.69 | 65-85 Years | F | 4 | 1.01 | 24 | 6.03 | ||
M | 14 | 4.93 | M | 20 | 5.03 | ||||||||
NA | 1 | 0.35 | NA | 0 | 0.00 | ||||||||
> 85 Years | F | 0 | 0.00 | 0 | 0.00 | > 85 Years | F | 0 | 0 | 0 | 0.00 | ||
M | 0 | 0.00 | M | 0 | 0 | ||||||||
NA | 0 | 0.00 | NA | 0 | 0 | ||||||||
Not Specified | F | 13 | 4.58 | 53 | 18.66 | Not Specified | F | 26 | 6.53 | 133 | 33.42 | ||
M | 22 | 7.75 | M | 45 | 11.31 | ||||||||
NA | 18 | 6.34 | NA | 62 | 15.58 | ||||||||
Total | 284 | 100 | 284 | 100 | Total | 398 | 100 | 398 | 100 | ||||
Age | Sex | Subtotal | % | Total | % | Age | Sex | Subtotal | % | Total | % | ||
Axicabtagene ciloleucel | 2 months - 2 years | F | 0 | 0 | 0 | 0.00 | Axicabtagene ciloleucel | 2 months - 2 years | F | 0 | 0 | 0 | 0.00 |
M | 0 | 0 | M | 0 | 0 | ||||||||
NA | 0 | 0 | NA | 0 | 0 | ||||||||
3-11 years | F | 0 | 0 | 0 | 0.00 | 3-11 years | F | 0 | 0 | 0 | 0.00 | ||
M | 0 | 0 | M | 0 | 0 | ||||||||
NA | 0 | 0 | NA | 0 | 0 | ||||||||
12-17 Years | F | 1 | 0.15 | 1 | 0.15 | 12-17 Years | F | 0 | 0 | 0 | 0.00 | ||
M | 0 | 0 | M | 0 | 0 | ||||||||
NA | 0 | 0 | NA | 0 | 0 | ||||||||
18-64 Years | F | 92 | 13.47 | 277 | 40.56 | 18-64 Years | F | 118 | 15.88 | 337 | 45.36 | ||
M | 165 | 24.16 | M | 208 | 27.99 | ||||||||
NA | 20 | 2.93 | NA | 11 | 1.48 | ||||||||
65-85 Years | F | 62 | 9.08 | 149 | 21.81 | 65-85 Years | F | 66 | 8.88 | 202 | 27.19 | ||
M | 81 | 11.86 | M | 125 | 16.82 | ||||||||
NA | 6 | 0.87 | NA | 11 | 1.48 | ||||||||
> 85 Years | F | 1 | 0.15 | 2 | 0.30 | > 85 Years | F | 2 | 0.27 | 2 | 0.27 | ||
M | 1 | 0.15 | M | 0 | 0 | ||||||||
NA | 0 | 0 | NA | 0 | 0 | ||||||||
Not Specified | F | 39 | 5.71 | 254 | 37.19 | Not Specified | F | 40 | 5.38 | 202 | 27.19 | ||
M | 59 | 8.64 | M | 54 | 7.27 | ||||||||
NA | 156 | 22.84 | NA | 108 | 14.54 | ||||||||
Total | 683 | 100 | 683 | 100 | Total | 743 | 100 | 743 | 100.00 |