Patient characteristics
| . | All safety population (N = 207) . |
|---|---|
| Demographics | |
| Median (range), y | 75 (43-94) |
| ≥75 y, n (%) | 113 (54.6) |
| Male sex, n (%) | 114 (55.1) |
| Patient disposition | |
| Tertiary MC, n (%) | 148 (71.5) |
| Nontertiary MC, n (%) | 59 (28.5) |
| AML type, n (%) | |
| De novo | 92 (44.4) |
| Secondary AML | 111 (53.7) |
| Secondary AML, n/N (%) | |
| t-AML | 32/111 (28.8) |
| History of MDS | 52/111 (46.8) |
| History of MPN | 27/111 (24.3) |
| Previously treated with HMA for MDS, n/N (%) | |
| Yes | 13/52 (25) |
| ECOG PS score, n (%)∗ | |
| 0-1 | 136 (65.7) |
| 2-4 | 67 (32.3) |
| Missing | 4 (1.9) |
| ELN risk category, n (%)† | |
| Favorable | 20 (9.7) |
| Intermediate | 79 (38.2) |
| Poor | 73 (35.3) |
| Unknown/missing | 35 (16.9) |
| Baseline cytopenia grade ≥3‡ | |
| Anemia, n (%) | 41 (19.8) |
| Neutropenia, n (%) | 127 (61.4) |
| Thrombocytopenia, n (%) | 85 (41.1) |
| Baseline transfusion dependence, n (%)§ | |
| RBCs | 79 (38.2) |
| Platelets | 32 (15.5) |
| Chromosomal abnormalities, n (%) | |
| Normal karyotype | 65 (31.4) |
| Monosomal | 16 (7.7) |
| Complex karyotype | 32 (15.5) |
| Other karyotype change | 45 (21.7) |
| Technically unsuccessful | 36 (17.4) |
| Not done or unknown | 13 (6.3) |
| Genetic abnormalities, n/N assessed (%) | |
| FLT3-ITD | 14/135 (10.4) |
| NPM1 | 21/131 (16.0) |
| IDH1 | 10/77 (13.0) |
| IDH2 | 9/72 (12.5) |
| TP53 | 4/26 (15.4) |
| Main reason for choosing Ven therapy, n (%) | |
| Disease-related factors | 46 (22.2) |
| Patient-related factors | 158 (76.3) |
| Missing | 3 (1.4) |
| Main reason patient not eligible for induction therapy, n (%) | |
| Age of ≥75 y | 88 (42.5) |
| Patient unlikely to benefit from intensive induction because of disease risk | 46 (22.2) |
| ECOG PS score of ≥2 | 33 (15.9) |
| Other | 37 (17.8) |
| Missing | 3 (1.4) |
| . | All safety population (N = 207) . |
|---|---|
| Demographics | |
| Median (range), y | 75 (43-94) |
| ≥75 y, n (%) | 113 (54.6) |
| Male sex, n (%) | 114 (55.1) |
| Patient disposition | |
| Tertiary MC, n (%) | 148 (71.5) |
| Nontertiary MC, n (%) | 59 (28.5) |
| AML type, n (%) | |
| De novo | 92 (44.4) |
| Secondary AML | 111 (53.7) |
| Secondary AML, n/N (%) | |
| t-AML | 32/111 (28.8) |
| History of MDS | 52/111 (46.8) |
| History of MPN | 27/111 (24.3) |
| Previously treated with HMA for MDS, n/N (%) | |
| Yes | 13/52 (25) |
| ECOG PS score, n (%)∗ | |
| 0-1 | 136 (65.7) |
| 2-4 | 67 (32.3) |
| Missing | 4 (1.9) |
| ELN risk category, n (%)† | |
| Favorable | 20 (9.7) |
| Intermediate | 79 (38.2) |
| Poor | 73 (35.3) |
| Unknown/missing | 35 (16.9) |
| Baseline cytopenia grade ≥3‡ | |
| Anemia, n (%) | 41 (19.8) |
| Neutropenia, n (%) | 127 (61.4) |
| Thrombocytopenia, n (%) | 85 (41.1) |
| Baseline transfusion dependence, n (%)§ | |
| RBCs | 79 (38.2) |
| Platelets | 32 (15.5) |
| Chromosomal abnormalities, n (%) | |
| Normal karyotype | 65 (31.4) |
| Monosomal | 16 (7.7) |
| Complex karyotype | 32 (15.5) |
| Other karyotype change | 45 (21.7) |
| Technically unsuccessful | 36 (17.4) |
| Not done or unknown | 13 (6.3) |
| Genetic abnormalities, n/N assessed (%) | |
| FLT3-ITD | 14/135 (10.4) |
| NPM1 | 21/131 (16.0) |
| IDH1 | 10/77 (13.0) |
| IDH2 | 9/72 (12.5) |
| TP53 | 4/26 (15.4) |
| Main reason for choosing Ven therapy, n (%) | |
| Disease-related factors | 46 (22.2) |
| Patient-related factors | 158 (76.3) |
| Missing | 3 (1.4) |
| Main reason patient not eligible for induction therapy, n (%) | |
| Age of ≥75 y | 88 (42.5) |
| Patient unlikely to benefit from intensive induction because of disease risk | 46 (22.2) |
| ECOG PS score of ≥2 | 33 (15.9) |
| Other | 37 (17.8) |
| Missing | 3 (1.4) |
ECOG PS scores range from 0 to 5, with 0 indicating no symptoms and higher scores indicating greater disability.
Based on ELN 2017 criteria, as per investigator discretion.
Cytopenia was graded according to the common terminology criteria for AEs.
Baseline transfusion dependence was transfusion within 8 weeks before the first dose of Ven.