Table 2.
Most common AEs, CRS, and neurologic events in patients ≥65 years.
| Axi-Cel, N = 49 | SOC, N = 55 | |||
|---|---|---|---|---|
| n (%) | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
| Any AE | 49 (100) | 46 (94) | 55 (100) | 45 (82) |
| Pyrexia | 47 (96) | 4 (8) | 14 (25) | 0 |
| Neutropeniaa | 39 (80) | 39 (80) | 24 (44) | 24 (44) |
| Nausea | 23 (47) | 1 (2) | 37 (67) | 3 (5) |
| Anemia | 22 (45) | 19 (39) | 32 (58) | 25 (45) |
| Thrombocytopeniab | 21 (43) | 14 (29) | 37 (67) | 35 (64) |
| Leukopeniac | 19 (39) | 18 (37) | 10 (18) | 10 (18) |
| Fatigue | 17 (35) | 2 (4) | 31 (56) | 1 (2) |
| Diarrhea | 17 (35) | 1 (2) | 24 (44) | 0 |
| Decreased appetite | 18 (37) | 2 (4) | 19 (35) | 2 (4) |
| Hypokalemia | 16 (33) | 7 (14) | 17 (31) | 5 (9) |
| Hypotension | 23 (47) | 6 (12) | 8 (15) | 1 (2) |
| Constipation | 9 (18) | 0 | 21 (38) | 0 |
| Headache | 14 (29) | 0 | 14 (25) | 1 (2) |
| Hypophosphatemia | 20 (41) | 15 (31) | 8 (15) | 7 (13) |
| Cough | 18 (37) | 0 | 9 (16) | 0 |
| Edema peripheral | 9 (18) | 0 | 15 (27) | 1 (2) |
| Vomiting | 5 (10) | 0 | 18 (33) | 1 (2) |
| Chills | 18 (37) | 0 | 4 (7) | 0 |
| Hypocalcemia | 16 (33) | 0 | 6 (11) | 0 |
| Sinus tachycardia | 18 (37) | 1 (2) | 4 (7) | 0 |
| Confusional state | 19 (39) | 6 (12) | 2 (4) | 0 |
| Hypoxia | 15 (31) | 8 (16) | 6 (11) | 4 (7) |
| Hypomagnesemia | 7 (14) | 1 (2) | 13 (24) | 1 (2) |
| Acute kidney injury | 7 (14) | 1 (2) | 12 (22) | 3 (5) |
| Lymphocyte count decreased | 10 (20) | 10 (20) | 7 (13) | 7 (13) |
| Alanine aminotransferase increased | 10 (20) | 1 (2) | 4 (7) | 1 (2) |
| Hypoalbuminemia | 10 (20) | 1 (2) | 4 (7) | 0 |
| Encephalopathy | 12 (24) | 7 (14) | 1 (2) | 0 |
| Tremor | 12 (24) | 0 | 1 (2) | 0 |
| Febrile neutropenia | 0 | 0 | 12 (22) | 12 (22) |
| Hypogammaglobulinemia | 10 (20) | 0 | 1 (2) | 0 |
| Aphasia | 10 (20) | 3 (6) | 0 | 0 |
| CRS | 48 (98) | 4 (8) | — | — |
| Pyrexia | 47 (98) | 3 (6) | — | — |
| Hypotension | 21 (44) | 5 (10) | — | — |
| Sinus tachycardia | 16 (33) | 1 (2) | — | — |
| Chills | 13 (27) | 0 | — | — |
| Hypoxia | 12 (25) | 6 (13) | — | — |
| Headache | 8 (17) | 0 | — | — |
| Neurologic events | 32 (65) | 13 (27) | 14 (25) | 1 (2) |
| Confusional state | 19 (39) | 6 (12) | 2 (4) | 0 |
| Encephalopathy | 12 (24) | 7 (14) | 1 (2) | 0 |
| Tremor | 12 (24) | 0 | 1 (2) | 0 |
| Aphasia | 10 (20) | 3 (6) | 0 | 0 |
| Somnolence | 5 (10) | 3 (6) | 2 (4) | 0 |
| Delirium | 1 (2) | 1 (2) | 4 (7) | 1 (2) |
| Paresthesia | 0 | 0 | 5 (9) | 0 |
Note: Shown are any adverse events of any grade that occurred in at least 20% of the patients in either the axi-cel arm or the SOC arm, as well as events of the CRS that occurred in at least 15% of the patients in the axi-cel arm and neurologic events of any grade that occurred in at least 15% of the patients in the axi-cel arm or at least 3% of those in the SOC arm. The severity of the CRS was graded according to Lee and colleagues (18). Neurologic events were identified with the use of a prespecified search list of preferred terms in the Medical Dictionary for Regulatory Activities, version 23.1, on the basis of known neurotoxic effects associated with anti-CD19 immunotherapy, and were specifically identified with the use of methods that were based on the phase II study of blinatumomab (19). The severity of all adverse events, including neurologic events and symptoms of the CRS, was graded with the use of the Common Terminology Criteria for Adverse Events, version 4.03, of the NCI.
aNeutropenia refers to the combined preferred terms of neutropenia and neutrophil count decreased.
bThrombocytopenia refers to the combined preferred terms of thrombocytopenia and platelet count decreased.
cLeukopenia refers to the combined preferred terms of leukopenia and white-cell count decreased.