Table 3:
Treatment-emergent adverse events (safety set)
| Any grade | Grade 3 | Grade 4 | Grade 5 | |
|---|---|---|---|---|
|
| ||||
| Any treatment-emergent adverse event | 117 (100%) | 18 (15%) | 85 (73%) | 5 (4%)* |
| Cytokine release syndrome | 99 (85%) | 10 (9%) | 0 | 0 |
| Anaemia | 78 (67%) | 61 (52%) | 0 | 0 |
| Neutropenia | 72 (62%) | 11 (9%) | 60 (51%) | 0 |
| Thrombocytopenia | 58 (50%) | 14 (12%) | 34 (29%) | 0 |
| Fatigue | 40 (34%) | 7 (6%) | 0 | 0 |
| Nausea | 39 (33%) | 0 | 0 | 0 |
| Diarrhoea | 34 (29%) | 1 (1%) | 0 | 0 |
| Headache | 34 (29%) | 1 (1%) | 0 | 0 |
| Leukopenia | 34 (29%) | 3 (3%) | 28 (24%) | 0 |
| Hypokalaemia | 32 (27%) | 2 (2%) | 0 | 0 |
| Pyrexia | 32 (27%) | 1 (1%) | 0 | 0 |
| Confusional state | 31 (26%) | 11 (9%) | 0 | 0 |
| Hypocalcaemia | 30 (26%) | 5 (4%) | 0 | 0 |
| Constipation | 29 (25%) | 0 | 0 | 0 |
| Decreased appetite | 29 (25%) | 4 (3%) | 0 | 0 |
| Dizziness | 29 (25%) | 0 | 0 | 0 |
| Hypophosphataemia | 28 (24%) | 14 (12%) | 2 (2%) | 0 |
| Tremor | 28 (24%) | 2 (2%) | 0 | 0 |
| Lymphopenia | 24 (21%) | 7 (6%) | 16 (14%) | 0 |
| Hypomagnesaemia | 24 (21%) | 0 | 0 | 0 |
| Decreased blood fibrinogen | 23 (20%) | 6 (5%) | 0 | 0 |
| Hyperglycaemia | 23 (20%) | 10 (9%) | 2 (2%) | 0 |
Data are n (%). The table includes the most common treatment-emergent adverse events (≥20%) in the full population (n=117). Liso-cel=lisocabtagene maraleucel.
Four of the five deaths from adverse events were considered by investigators to be unrelated to liso-cel (respiratory failure, sepsis, Escherichia coli infection, and invasive aspergillosis; n=1 each) and one death was related to liso-cel (macrophage activation syndrome-haemophagocytic lymphohistiocytosis)