Summary of AEs during and after the TE period
| . | During TE period∗ (N = 270) . | Post-TE period† (N = 249) . | ||
|---|---|---|---|---|
| Patients with any-grade AEs, n (%) | 268 (99) | 105 (42) | ||
| Grade ≥3 | 213 (79) | 57 (23) | ||
| Grade 5 | 7 (3) | 5 (2) | ||
| Serious | 122 (45) | 42 (17) | ||
| Patients with most common AEs,‡ n (%) | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
| Neutropenia | 169 (63) | 161 (60) | 21 (8) | 17 (7) |
| Anemia | 129 (48) | 101 (37) | 19 (8) | 16 (6) |
| Fatigue | 119 (44) | 4 (1) | 18 (7) | 1 (<1) |
| CRS | 113 (42) | 6 (2) | 5 (2) | 1 (<1) |
| Nausea | 90 (33) | 4 (1) | 15 (6) | 0 |
| Thrombocytopenia | 85 (31) | 73 (27) | 16 (6) | 10 (4) |
| Headache | 80 (30) | 3 (1) | 8 (3) | 1 (<1) |
| Decreased appetite | 77 (29) | 7 (3) | 10 (4) | 1 (<1) |
| Diarrhea | 71 (26) | 1 (<1) | 13 (5) | 2 (<1) |
| Constipation | 63 (23) | 0 | 8 (3) | 0 |
| Dizziness | 60 (22) | 1 (<1) | 5 (2) | 0 |
| Hypotension | 60 (22) | 8 (3) | 5 (2) | 0 |
| Cough | 57 (21) | 0 | 6 (2) | 0 |
| Vomiting | 56 (21) | 1 (<1) | 7 (3) | 0 |
| Hypokalemia | 52 (19) | 6 (2) | 5 (2) | 0 |
| Hypomagnesemia | 50 (19) | 1 (<1) | 5 (2) | 0 |
| Abdominal pain | 45 (17) | 5 (2) | 6 (2) | 1 (<1) |
| Pyrexia | 45 (17) | 0 | 11 (4) | 0 |
| Leukopenia | 44 (16) | 39 (14) | 4 (2) | 2 (<1) |
| Peripheral edema | 42 (16) | 1 (<1) | 6 (2) | 1 (<1) |
| Sinus tachycardia | 42 (16) | 0 | 3 (1) | 0 |
| Tremor | 41 (15) | 0 | 0 | 0 |
| Confusional state | 39 (14) | 2 (<1) | 4 (2) | 0 |
| Hypertension | 37 (14) | 12 (4) | 0 | 0 |
| Hypogammaglobulinemia§ | 37 (14) | 0 | 13 (5) | 0 |
| Dyspnea | 36 (13) | 2 (<1) | 4 (2) | 1 (<1) |
| Insomnia | 36 (13) | 1 (<1) | 9 (4) | 0 |
| Back pain | 33 (12) | 3 (1) | 3 (1) | 1 (<1) |
| Chills | 31 (11) | 0 | 4 (2) | 0 |
| Anxiety | 27 (10) | 0 | 5 (2) | 0 |
| Hypophosphatemia | 27 (10) | 16 (6) | 3 (1) | 2 (<1) |
| Febrile neutropenia | 25 (9) | 24 (9) | 10 (4) | 9 (4) |
| Myelodysplastic syndrome | 1 (<1) | 1 (<1) | 7 (3) | 7 (3) |
| Basal cell carcinoma | 1 (<1) | 0 | 5 (2) | 2 (<1) |
| . | During TE period∗ (N = 270) . | Post-TE period† (N = 249) . | ||
|---|---|---|---|---|
| Patients with any-grade AEs, n (%) | 268 (99) | 105 (42) | ||
| Grade ≥3 | 213 (79) | 57 (23) | ||
| Grade 5 | 7 (3) | 5 (2) | ||
| Serious | 122 (45) | 42 (17) | ||
| Patients with most common AEs,‡ n (%) | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
| Neutropenia | 169 (63) | 161 (60) | 21 (8) | 17 (7) |
| Anemia | 129 (48) | 101 (37) | 19 (8) | 16 (6) |
| Fatigue | 119 (44) | 4 (1) | 18 (7) | 1 (<1) |
| CRS | 113 (42) | 6 (2) | 5 (2) | 1 (<1) |
| Nausea | 90 (33) | 4 (1) | 15 (6) | 0 |
| Thrombocytopenia | 85 (31) | 73 (27) | 16 (6) | 10 (4) |
| Headache | 80 (30) | 3 (1) | 8 (3) | 1 (<1) |
| Decreased appetite | 77 (29) | 7 (3) | 10 (4) | 1 (<1) |
| Diarrhea | 71 (26) | 1 (<1) | 13 (5) | 2 (<1) |
| Constipation | 63 (23) | 0 | 8 (3) | 0 |
| Dizziness | 60 (22) | 1 (<1) | 5 (2) | 0 |
| Hypotension | 60 (22) | 8 (3) | 5 (2) | 0 |
| Cough | 57 (21) | 0 | 6 (2) | 0 |
| Vomiting | 56 (21) | 1 (<1) | 7 (3) | 0 |
| Hypokalemia | 52 (19) | 6 (2) | 5 (2) | 0 |
| Hypomagnesemia | 50 (19) | 1 (<1) | 5 (2) | 0 |
| Abdominal pain | 45 (17) | 5 (2) | 6 (2) | 1 (<1) |
| Pyrexia | 45 (17) | 0 | 11 (4) | 0 |
| Leukopenia | 44 (16) | 39 (14) | 4 (2) | 2 (<1) |
| Peripheral edema | 42 (16) | 1 (<1) | 6 (2) | 1 (<1) |
| Sinus tachycardia | 42 (16) | 0 | 3 (1) | 0 |
| Tremor | 41 (15) | 0 | 0 | 0 |
| Confusional state | 39 (14) | 2 (<1) | 4 (2) | 0 |
| Hypertension | 37 (14) | 12 (4) | 0 | 0 |
| Hypogammaglobulinemia§ | 37 (14) | 0 | 13 (5) | 0 |
| Dyspnea | 36 (13) | 2 (<1) | 4 (2) | 1 (<1) |
| Insomnia | 36 (13) | 1 (<1) | 9 (4) | 0 |
| Back pain | 33 (12) | 3 (1) | 3 (1) | 1 (<1) |
| Chills | 31 (11) | 0 | 4 (2) | 0 |
| Anxiety | 27 (10) | 0 | 5 (2) | 0 |
| Hypophosphatemia | 27 (10) | 16 (6) | 3 (1) | 2 (<1) |
| Febrile neutropenia | 25 (9) | 24 (9) | 10 (4) | 9 (4) |
| Myelodysplastic syndrome | 1 (<1) | 1 (<1) | 7 (3) | 7 (3) |
| Basal cell carcinoma | 1 (<1) | 0 | 5 (2) | 2 (<1) |
Most common AEs are listed in descending order of incidence in the TE period.
TE, treatment-emergent.
The TE period started any time from initiation of liso-cel administration to and including 90 days after liso-cel infusion. Any AE occurring after the initiation of another anticancer therapy or liso-cel retreatment were not considered as a TEAE.
The posttreatment-emergent period started from 91 days after liso-cel infusion or from initiation of another anticancer therapy or liso-cel retreatment (if patients initiated another anticancer therapy or liso-cel retreatment before 91 days after liso-cel infusion).
Any-grade AEs occurring in ≥10% in the TE period or ≥2% in the post-TE period.
Includes events occurring after liso-cel infusion coded to the following Medical Dictionary for Regulatory Activities preferred terms: blood IgA decreased, blood IgD decreased, blood IgE decreased, blood IgG decreased, blood IgM decreased, hypogammaglobulinemia, Igs decreased, selective IgA immunodeficiency, selective IgG subclass deficiency, and selective IgM immunodeficiency.