Table 2 Patients with at least one TEAE by seriousness, relatedness, and severity.
PLX-R18 | PLX-R18 | PLX-R18 | Overall | |
---|---|---|---|---|
1 M cells/kg (Cohort 1) | 2 M cells/kg (Cohort 2) | 4 M cells/kg (Cohort 3) | ||
N = 3 | N = 6 | N = 12 | N = 21 | |
n (%) | n (%) | n (%) | n (%) | |
Patients with any TEAEs [1] | 3 (100.0) | 6 (100.0) | 12 (100.0) | 21 (100.0) |
Patients with any serious TEAEs | 3 (100.0) | 4 (66.7) | 8 (66.7) | 15 (71.4) |
Patients with TEAEs with fatal outcome | 0 | 2 (33.3) | 2 (16.7) | 4 (19.0) |
Patients with TEAEs by relationship throughout the study [2] | ||||
Related | 3 (100.0) | 2 (33.3) | 11 (91.7) | 16 (76.2) |
Not related | 0 | 4 (66.7) | 1 (8.3) | 5 (23.8) |
Patients with TEAEs by highest severity throughout the study [2] | ||||
Mild – Grade 1 | 0 | 0 | 3 (25.0) | 3 (14.3) |
Moderate – Grade 2 | 0 | 2 (33.3) | 2 (16.7) | 4 (19.0) |
Severe – Grade 3-5 | 3 (100.0) | 4 (66.7) | 7 (58.3) | 14 (66.7) |