Table 2.
Descriptive analyses of the main characteristics of the CAR-T reports vs reports of reference groups
| Axi-cel N (%) |
Tisa-cel N (%) |
RG1 N (%) |
RG2 N (%) |
RG3 N (%) |
|
|---|---|---|---|---|---|
| No. of reports | 1793 | 1433 | 3,250,642 | 142,083 | 74,170 |
| Sex | |||||
| Female | 629 (39.5) | 517 (40.4) | 1,777,421 (61.3) | 73,244 (56.9) | 41,768 (56.9) |
| Male | 963 (60.5) | 763 (59.6) | 1,124,251 (38.7) | 55,561 (43.1) | 31,641 (43.1) |
| Missing/other | 201 | 153 | 348,970 | 13,278 | 761 |
| Age group, years | |||||
| < 18 | 5 (0.4) | 480 (42.4) | 134,880 (6.6) | 5807 (7.3) | – |
| 18–64 | 899 (63.4) | 438 (38.7) | 1,149,796 (56.2) | 37,746 (47.2) | 37,746 (50.9) |
| ≥ 65 | 513 (36.2) | 214 (18.9) | 762,302 (37.2) | 36,424 (45.5) | 36,424 (49.1) |
| Median [Q1–Q3] | 61 [52–68] | 21 [12–60] | 59 [41–70] | 63 [50–72] | 64 [54–73] |
| Missing | 376 | 301 | 1,203,664 | 62,106 | – |
| Country | |||||
| North America | 1469 (82.0) | 1176 (84.5) | 2,422,692 (77.2) | 99,246 (72.3) | 46,974 (65.8) |
| Europe | 310 (17.3) | 170 (12.2) | 496,833 (15.8) | 28,104 (20.5) | 17,484 (24.5) |
| Asia | 12 (0.7) | 46 (3.3) | 219,408 (7.0) | 9933 (7.2) | 6950 (9.7) |
| Missing/other | 2 | 41 | 111,709 | 4800 | 2726 |
| Reporter type | |||||
| Consumer | 109 (6.4) | 229 (16.1) | 1,483,749 (46.9) | 28,796 (20.4) | 14,078 (19.2) |
| Medical doctor | 604 (35.6) | 769 (54.2) | 713,944 (22.6) | 40,133 (28.4) | 22,621 (30.6) |
| Pharmacist | 114 (6.7) | 15 (1.1) | 272,985 (8.6) | 32,475 (23.0) | 13,726 (18.6) |
| Healthcare practitioner | 298 (17.6) | 203 (14.3) | 205,650 (6.5) | 15,532 (11.0) | 9533 (12.9) |
| Specified as other | 572 (33.7) | 202 (14.3) | 449,577 (14.2) | 24,368 (17.2) | 13,828 (18.7) |
| Missing | 96 | 15 | 124,737 | 779 | 384 |
| Reporting year | |||||
| 2017 (Oct–Dec) | 3 (0.1) | 23 (1.6) | 232,984 (7.2) | 9224 (6.5) | 4987 (6.7) |
| 2018 | 475 (26.5) | 269 (18.8) | 1,072,523 (33.0) | 44,388 (31.2) | 23,929 (32.3) |
| 2019 | 731 (40.8) | 706 (49.3) | 1,125,114 (34.6) | 47,480 (33.4) | 24,688 (33.3) |
| 2020 (Jan–Sep) | 584 (32.6) | 435 (30.3) | 820,021 (25.2) | 40,991 (28.9) | 20,566 (27.7) |
| Specified as serious | 1696 (94.6) | 1345 (93.9) | 1,826,595 (56.2) | 109,288 (76.9) | 64,213 (86.6) |
| Seriousness | |||||
| Death | 298 (16.6) | 387 (27.0) | 266,475 (8.2) | 14,976 (10.5) | 9458 (12.8) |
| Life threatening | 83 (4.6) | 100 (7.0) | 73,516 (2.3) | 4184 (2.9) | 2767 (3.7) |
| Disability | 24 (1.3) | 4 (0.3) | 42,501 (1.3) | 1964 (1.4) | 1319 (1.8) |
| Required intervention | 1 (0.1) | 0 (0) | 2597 (0.1) | 4 (<0.1) | 3 (<0.1) |
| Hospitalization | 592 (33.0) | 293 (20.4) | 613,184 (18.9) | 37,346 (26.3) | 23,846 (32.2) |
| Congenital abnormality | 0 (0) | 1 (0.1) | 6298 (0.2) | 82 (0.1) | 18 (<0.1) |
| Other serious | 698 (38.9) | 560 (39.1) | 822,024 (25.3) | 50,732 (35.7) | 26,802 (36.1) |
| Drugs per report median [Q1–Q3] | 1 [1–6] | 3 [1–4] | 2 [1–4] | 7 [4–12] | 8 [4–13] |
| Suspected drugs per report median [Q1–Q3] | 1 [1–1] | 1 [1–1] | 1 [1–2] | 2 [1–3] | 2 [1–4] |
| Events per report median [Q1–Q3] | 3 [1–5] | 5 [2–9] | 2 [1–4] | 2 [1–5] | 3 [1–6] |
To account for the incompleteness characteristic of spontaneous reporting databases, percentages were calculated for each variable, over reports with a specified value (valid percentage)
Axi-cel axicabtagene ciloleucel, CAR-T chimeric antigen receptor T, RG1 reference group 1 (all reports other than the ones related CAR-T cells), RG2 reference group 2 (reports related to onco-hematological drugs with indication for use specified for acute lymphoblastic leukemia or diffuse large B-cell lymphoma), RG3 reference group 3 (onco-hematological drug reports with indication for use specified for acute lymphoblastic leukemia or diffuse large B-cell lymphoma in adult population specifically), Tisa-cel tisagenlecleucel