Table 1.
Population characteristics by PML reporting status among patients treated with CD19-CAR-T and reported to FAERS
| PML reports (n = 11) | Non-PML reports (n = 4026) | P value | |
|---|---|---|---|
| Reporting region | |||
| Americas | 5/11 (45.5) | 3291/4025 | .010 |
| Europe | 5/11 (45.5) | 618/4025 | |
| Asia | 1/11 (9.0) | 60/4025 | |
| Australia | 0/11 (0.00) | 56/4025 | |
| Reporter | |||
| Health professional | 10/11 (90.9) | 3559/3914 (90.9) | >.99 |
| Consumer/lawyer | 1/11 (9.1) | 355/3914 (9.1) | |
| Event year | |||
| 2018 | 0/8 (0.0) | 729/2429 (29.9) | .040 |
| 2019 | 2/8 (25.0) | 934/2429 (38.5) | |
| 2020 | 6/8 (75.0) | 705/2429 (29.0) | |
| 2021∗ | 0/8 (0.0) | 61/2429 (2.5) | |
| Age, y | |||
| Median (IQR) | 63 (58-67) n = 10 | 57 (28-67) n = 2882 | .163 |
| Sex | |||
| Female | 7/10 (70.0) | 1254/3255 (38.5) | .052 |
| Male | 3/10 (30.0) | 2001/3255 (61.5) | |
| Product | |||
| Axicabtagene-ciloleucel | 7/11 (63.6) | 2331/4026 (57.9) | .770 |
| Tisagenlecleucel | 4/11 (36.4) | 1695/4026 (42.1) | |
| Indication | |||
| NHL | 9/10 (90.0) | 2474/3316 (74.6) | .544 |
| ALL | 1/10 (10.0) | 791/3316 (23.9) | |
| Other | 0/10 (0.0) | 51/3316 (1.5) | |
| Time to AE onset, mo | |||
| Median (IQR) | 8 (8-15) n = 10 | 0.13 (0.03-0.33) n = 1983 | <.001 |
| Min-max | 6-31 n = 10 | 0-82 n = 1983 | |
| Reported fatality rate | 7/9 (77.8) | 906/3831 (23.6) | <.001 |
All values are n (%) unless otherwise indicated.
IQR, interquartile range.
∗
Only cases reported before 31 March 2021 were included.