Characteristics of FAERS CAR T reports
| . | All CAR T reports . | All SPM CAR T reports . | Axi-cel SPM reports . | Tisa-cel SPM reports . | Brexu-cel SPM reports . | Liso-cel SPM reports . | Ide-cel SPM reports . | Cilta-cel SPM reports . |
|---|---|---|---|---|---|---|---|---|
| N | 12 394 | 536 | 277 | 177 | 20 | 23 | 15 | 24 |
| Age, y | ||||||||
| Mean (SD) | 53.8 (20.5) | 58.7 (18.2) | 61.3 (11.1) | 50.1 (26.2) | 58.4 (18.8) | 69.4 (9.9) | 65.0 (8.3) | 68.5 (7.8) |
| Median (IQR) | 60.0 (45.0-68.0) | 63.0 (56.0-70.0) | 62.0 (56.0-68.0) | 62.0 (20.0-70.8) | 62.0 (60.3-70.3) | 71.0 (67.0-76.0) | 66.5 (56.0-70.0) | 71.0 (63.0-75.0) |
| Missing | 3 884 | 131 | 62 | 55 | 6 | 2 | 3 | 3 |
| Sex (%) | ||||||||
| Female | 3 813 (38.1) | 181 (36.8) | 91 (34.5) | 68 (44.2) | 3 (16.7) | 10 (45.5) | 3 (23.1) | 6 (28.6) |
| Male | 6 182 (61.9) | 311 (63.2) | 173 (65.5) | 86 (55.8) | 15 (83.3) | 12 (54.5) | 10 (76.9) | 15 (71.4) |
| Missing | 2 399 | 44 | 13 | 23 | 2 | 1 | 2 | 3 |
| Mean weight (SD), kg | 75.78 (24.6) | 74.21 (24.1) | 75.73 (18.9) | 68.73 (28.4) | 74.5 (23.9) | 84.5 (27.1) | 78.9 (8.8) | 76.9 (17.0) |
| Reporter (%) | ||||||||
| Consumer | 1 274 (11.4) | 24 (4.6) | 10 (3.7) | 13 (7.6) | 0 (0.0) | 0 (0.0) | 1 (6.7) | 0 (0.0) |
| Health care practitioner | 4 844 (43.3) | 220 (42.3) | 153 (56.9) | 53 (30.8) | 9 (50.0) | 3 (13.6) | 0 (0.0) | 2 (8.3) |
| Physician | 5 075 (45.3) | 276 (53.1) | 106 (39.4) | 106 (61.6) | 9 (50.0) | 19 (86.4) | 14 (93.3) | 22 (91.7) |
| Missing | 1 201 | 16 | 8 | 5 | 2 | 1 | 0 | 0 |
| Reporting region (%) | ||||||||
| North America | 7 530 (66.7) | 346 (66.3) | 201 (73.6) | 95 (54.0) | 11 (64.7) | 16 (84.2) | 7 (50.0) | 16 (69.6) |
| Europe | 2 890 (25.6) | 151 (28.9) | 70 (25.6) | 62 (35.2) | 6 (35.3) | 1 (5.3) | 7 (50.0) | 5 (21.7) |
| Asia | 613 (5.4) | 17 (3.3) | 1 (0.4) | 14 (8.0) | 0 (0.0) | 2 (10.5) | 0 (0.0) | 0 (0.0) |
| Africa | 1 (0.01) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Others | 261 (2.3) | 8 (1.5) | 1 (0.4) | 5 (2.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (8.7) |
| Missing | 1 099 | 14 | 4 | 1 | 3 | 4 | 1 | 1 |
| Report year (%) | ||||||||
| 2017 (October-December) | 72 (0.6) | 1 (0.2) | 0 (0.0) | 1 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 2018 | 833 (6.7) | 22 (4.1) | 9 (3.3) | 12 (6.8) | 0 (0.0) | 1 (4.4) | 0 (0.0) | 0 (0.0) |
| 2019 | 1 652 (13.3) | 43 (8.0) | 17 (6.1) | 26 (14.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 2020 | 1 752 (14.1) | 80 (14.9) | 52 (18.8) | 22 (12.4) | 0 (0.0) | 4 (17.4) | 2 (13.3) | 0 (0.0) |
| 2021 | 1 927 (15.6) | 114 (21.3) | 59 (21.3) | 41 (23.2) | 4 (20.0) | 9 (39.1) | 1 (6.7) | 0 (0.0) |
| 2022 | 2 611 (21.1) | 129 (24.1) | 80 (28.9) | 22 (12.4) | 5 (25.0) | 5 (21.7) | 6 (40.0) | 11 (45.8) |
| 2023 | 3 547 (28.6) | 147 (27.4) | 60 (21.7) | 53 (30.0) | 11 (55.0) | 4 (17.4) | 6 (40.0) | 13 (54.2) |
| Outcome specified as serious (%) | 11 571 (93.4%) | 530 (98.9) | 276 (99.6) | 176 (99.4) | 19 (95.0) | 23 (100.0) | 15 (100.0) | 21 (87.50) |
| Outcome (%) | ||||||||
| Death | 2 861 (24.7) | 207 (39.1) | 124 (44.9) | 67 (38.1) | 6 (31.6) | 4 (17.4) | 4 (26.7) | 2 (9.5) |
| Disability | 94 (0.8) | 17 (3.2) | 4 (1.5) | 11 (6.3) | 0 (0.0) | 0 (0.0) | 1 (6.7) | 1 (4.8) |
| Hospitalization | 1 860 (16.1) | 37 (7.0) | 14 (5.1) | 13 (7.4) | 5 (26.3) | 0 (0.0) | 2 (13.3) | 3 (14.3) |
| Life-threatening | 673 (5.8) | 15 (2.8) | 4 (1.5) | 9 (5.1) | 0 (0.0) | 0 (0.0) | 1 (6.7) | 1 (4.8) |
| Required intervention | 28 (0.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Other serious | 6 055 (52.3) | 254 (47.9) | 130 (47.1) | 76 (43.2) | 8 (42.1) | 19 (82.6) | 7 (46.7) | 14 (66.7) |
| Missing | 823 | 6 | 1 | 1 | 1 | 0 | 0 | 3 |
| . | All CAR T reports . | All SPM CAR T reports . | Axi-cel SPM reports . | Tisa-cel SPM reports . | Brexu-cel SPM reports . | Liso-cel SPM reports . | Ide-cel SPM reports . | Cilta-cel SPM reports . |
|---|---|---|---|---|---|---|---|---|
| N | 12 394 | 536 | 277 | 177 | 20 | 23 | 15 | 24 |
| Age, y | ||||||||
| Mean (SD) | 53.8 (20.5) | 58.7 (18.2) | 61.3 (11.1) | 50.1 (26.2) | 58.4 (18.8) | 69.4 (9.9) | 65.0 (8.3) | 68.5 (7.8) |
| Median (IQR) | 60.0 (45.0-68.0) | 63.0 (56.0-70.0) | 62.0 (56.0-68.0) | 62.0 (20.0-70.8) | 62.0 (60.3-70.3) | 71.0 (67.0-76.0) | 66.5 (56.0-70.0) | 71.0 (63.0-75.0) |
| Missing | 3 884 | 131 | 62 | 55 | 6 | 2 | 3 | 3 |
| Sex (%) | ||||||||
| Female | 3 813 (38.1) | 181 (36.8) | 91 (34.5) | 68 (44.2) | 3 (16.7) | 10 (45.5) | 3 (23.1) | 6 (28.6) |
| Male | 6 182 (61.9) | 311 (63.2) | 173 (65.5) | 86 (55.8) | 15 (83.3) | 12 (54.5) | 10 (76.9) | 15 (71.4) |
| Missing | 2 399 | 44 | 13 | 23 | 2 | 1 | 2 | 3 |
| Mean weight (SD), kg | 75.78 (24.6) | 74.21 (24.1) | 75.73 (18.9) | 68.73 (28.4) | 74.5 (23.9) | 84.5 (27.1) | 78.9 (8.8) | 76.9 (17.0) |
| Reporter (%) | ||||||||
| Consumer | 1 274 (11.4) | 24 (4.6) | 10 (3.7) | 13 (7.6) | 0 (0.0) | 0 (0.0) | 1 (6.7) | 0 (0.0) |
| Health care practitioner | 4 844 (43.3) | 220 (42.3) | 153 (56.9) | 53 (30.8) | 9 (50.0) | 3 (13.6) | 0 (0.0) | 2 (8.3) |
| Physician | 5 075 (45.3) | 276 (53.1) | 106 (39.4) | 106 (61.6) | 9 (50.0) | 19 (86.4) | 14 (93.3) | 22 (91.7) |
| Missing | 1 201 | 16 | 8 | 5 | 2 | 1 | 0 | 0 |
| Reporting region (%) | ||||||||
| North America | 7 530 (66.7) | 346 (66.3) | 201 (73.6) | 95 (54.0) | 11 (64.7) | 16 (84.2) | 7 (50.0) | 16 (69.6) |
| Europe | 2 890 (25.6) | 151 (28.9) | 70 (25.6) | 62 (35.2) | 6 (35.3) | 1 (5.3) | 7 (50.0) | 5 (21.7) |
| Asia | 613 (5.4) | 17 (3.3) | 1 (0.4) | 14 (8.0) | 0 (0.0) | 2 (10.5) | 0 (0.0) | 0 (0.0) |
| Africa | 1 (0.01) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Others | 261 (2.3) | 8 (1.5) | 1 (0.4) | 5 (2.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (8.7) |
| Missing | 1 099 | 14 | 4 | 1 | 3 | 4 | 1 | 1 |
| Report year (%) | ||||||||
| 2017 (October-December) | 72 (0.6) | 1 (0.2) | 0 (0.0) | 1 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 2018 | 833 (6.7) | 22 (4.1) | 9 (3.3) | 12 (6.8) | 0 (0.0) | 1 (4.4) | 0 (0.0) | 0 (0.0) |
| 2019 | 1 652 (13.3) | 43 (8.0) | 17 (6.1) | 26 (14.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 2020 | 1 752 (14.1) | 80 (14.9) | 52 (18.8) | 22 (12.4) | 0 (0.0) | 4 (17.4) | 2 (13.3) | 0 (0.0) |
| 2021 | 1 927 (15.6) | 114 (21.3) | 59 (21.3) | 41 (23.2) | 4 (20.0) | 9 (39.1) | 1 (6.7) | 0 (0.0) |
| 2022 | 2 611 (21.1) | 129 (24.1) | 80 (28.9) | 22 (12.4) | 5 (25.0) | 5 (21.7) | 6 (40.0) | 11 (45.8) |
| 2023 | 3 547 (28.6) | 147 (27.4) | 60 (21.7) | 53 (30.0) | 11 (55.0) | 4 (17.4) | 6 (40.0) | 13 (54.2) |
| Outcome specified as serious (%) | 11 571 (93.4%) | 530 (98.9) | 276 (99.6) | 176 (99.4) | 19 (95.0) | 23 (100.0) | 15 (100.0) | 21 (87.50) |
| Outcome (%) | ||||||||
| Death | 2 861 (24.7) | 207 (39.1) | 124 (44.9) | 67 (38.1) | 6 (31.6) | 4 (17.4) | 4 (26.7) | 2 (9.5) |
| Disability | 94 (0.8) | 17 (3.2) | 4 (1.5) | 11 (6.3) | 0 (0.0) | 0 (0.0) | 1 (6.7) | 1 (4.8) |
| Hospitalization | 1 860 (16.1) | 37 (7.0) | 14 (5.1) | 13 (7.4) | 5 (26.3) | 0 (0.0) | 2 (13.3) | 3 (14.3) |
| Life-threatening | 673 (5.8) | 15 (2.8) | 4 (1.5) | 9 (5.1) | 0 (0.0) | 0 (0.0) | 1 (6.7) | 1 (4.8) |
| Required intervention | 28 (0.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Other serious | 6 055 (52.3) | 254 (47.9) | 130 (47.1) | 76 (43.2) | 8 (42.1) | 19 (82.6) | 7 (46.7) | 14 (66.7) |
| Missing | 823 | 6 | 1 | 1 | 1 | 0 | 0 | 3 |
IQR, interquartile range; SD, standard deviation.