Treatment-emergent serious AEs
| Cohort . | 1 . | 2 . | 3 . | 4 . | 5 . | 6 . | 7 . | 8 . | 9 . | 10 . | 11 . | 12 . | 13 . | 14 . | 14.1 . | 15 . | All . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (33) [1] | 1 (17) [1] | 0 | 0 | 0 | 1 (17) [1] | 0 | 1 (17) [1] | 2 (33) [2] | 1 (25) [1] | 7 (10) [7] |
| Pyrexia | 0 | 1 (33) [1] | 0 | 1 (33) [1] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 1 (17) [1] | 1 (17) [1] | 0 | 0 | 5 (7) [5] |
| Cellulitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (33) [2] | 1 (17) [1] | 1 (17) [1] | 1 (25) [2] | 5 (7) [6] |
| Sepsis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (50) [3] | 1 (25) [1] | 0 | 1 (17) [1] | 0 | 0 | 0 | 4 (6) [5] |
| Respiratory failure | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25) [1] | 0 | 0 | 1 (17) [1] | 1 (17) [1] | 0 | 0 | 3 (4) [3] |
| Febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 0 | 1 (17) [1] | 0 | 2 (3) [2] |
| Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25) [1] | 2 (3) [2] |
| Multiorgan failure | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 1 (17) [1] | 0 | 2 (3) [2] |
| Urinary tract infection | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 0 | 0 | 0 | 1 (17) [1] | 0 | 0 | 0 | 0 | 2 (3) [2] |
| Cohort . | 1 . | 2 . | 3 . | 4 . | 5 . | 6 . | 7 . | 8 . | 9 . | 10 . | 11 . | 12 . | 13 . | 14 . | 14.1 . | 15 . | All . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (33) [1] | 1 (17) [1] | 0 | 0 | 0 | 1 (17) [1] | 0 | 1 (17) [1] | 2 (33) [2] | 1 (25) [1] | 7 (10) [7] |
| Pyrexia | 0 | 1 (33) [1] | 0 | 1 (33) [1] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 1 (17) [1] | 1 (17) [1] | 0 | 0 | 5 (7) [5] |
| Cellulitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (33) [2] | 1 (17) [1] | 1 (17) [1] | 1 (25) [2] | 5 (7) [6] |
| Sepsis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (50) [3] | 1 (25) [1] | 0 | 1 (17) [1] | 0 | 0 | 0 | 4 (6) [5] |
| Respiratory failure | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25) [1] | 0 | 0 | 1 (17) [1] | 1 (17) [1] | 0 | 0 | 3 (4) [3] |
| Febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 0 | 1 (17) [1] | 0 | 2 (3) [2] |
| Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25) [1] | 2 (3) [2] |
| Multiorgan failure | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 1 (17) [1] | 0 | 2 (3) [2] |
| Urinary tract infection | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 0 | 0 | 0 | 1 (17) [1] | 0 | 0 | 0 | 0 | 2 (3) [2] |
Data are reported as number of patients reporting TEAEs (percentage of patients reporting TEAEs) [number of TEAEs].