TABLE 2.
Overview of TEAEs for M8891
| Safety analysis set | 7 mg QD n = 3 |
12 mg QD n = 3 |
20 mg QD n = 3 |
35 mg QD n = 8 |
60 mg QD n = 7 |
80 mg QD n = 3 |
All patients n = 27 |
|---|---|---|---|---|---|---|---|
| All TEAEs | 3 (100) | 2 (66.7) | 3 (100) | 8 (100) | 7 (100) | 3 (100) | 26 (96.3) |
| M8891-related | 2 (66.7) | 1 (33.3) | 2 (66.7) | 6 (75.0) | 7 (100) | 3 (100) | 21 (77.8) |
| Serious TEAEs | 0 (0.0) | 1 (33.3) | 3 (100) | 3 (37.5) | 1 (14.3) | 0 (0.0) | 8 (29.6) |
| M8891-related | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (14.3)a | 0 (0.0) | 1 (3.7) |
| TEAEs leading to discontinuation | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (37.5) | 3 (42.9) | 1 (33.3) | 7 (25.9) |
| Dose-escalation set |
7 mg QD
n = 3 |
12 mg QD
n = 3 |
20 mg QD
n = 3 |
35 mg QD
n = 5 |
60 mg QD
n = 5 |
80 mg QD
n = 2 |
All patients
n = 20 |
| DLTs | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (20.0) | 1 (50.0) | 2 (10.0) |
| Platelet count decrease | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (20.0) | 1 (50.0) | 2 (10.0) |
Abbreviations: TEAE, treatment-emergent adverse event; QD, once daily.
aPlatelet count decrease that was also classified as a DLT and led to M8891 discontinuation.